40371

Organization name

I.R.A. Istituto Ricerche Applicate S.p.A.

SRN

IT-MF-000009981

Manufacturer status

Active

16 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW020

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW277

  EUDAMED did not publish a description for this code.
• CW135

  EUDAMED did not publish a description for this code.
• CW999

  To be implanted only in an appropriate medical setting by suitably trained, qualified or accredited doctors in accordance with national legislation.
• CW999

  STERILIZATION The contents of the syringes are moist heat sterilised. The exterior of the syringe is not sterile. Needles, if included within the package, are sterilised by irradiation.
• CW999

  CONTRAINDICATIONS The device must not be used: - for injections in the periorbital area (eyelids, dark circles); - for injections into blood vessels or nerves; - for breast tissue augmentation or for implantation in bones, tendons, ligaments or muscles. The device must not be administered to patients with: - known tendency to develop hypertrophic or keloid scars or pigmentation disorders; - previous autoimmune diseases in progress or undergoing immunotherapy; - multiple severe allergies or ongoing inflammatory processes; - coagulation disorders; - known hypersensitivity to hyaluronic acid. The device must not be used on pregnant or breastfeeding women, or on persons under the age of eighteen.
• CW999

  WARNINGS The device is intended to be injected subcutaneously or intradermally only and must not be injected intravascularly. The device is supplied as a sterile, single-use product and must not be resterilised. Do not reuse. It is not recommended to use needles other than those contained in the package or recommended in the instructions for use herein, in the "How to use" section. The Manufacturer cannot be held responsible for the safety and performance of the device if used with an inappropriate needle or in case of reuse. If supplied, do not use the supplied needles if the package is not perfectly intact or if they are bent and/or deformed. Do not use the device if the syringe or blister appears to be damaged. Do not use after the expiry date indicated on the packaging. Do not use the device in combination with other injectable products or mix it with other preparations before use. Do not use the product if the contents of the syringe appear cloudy or contain particles; in this case, promptly inform I.R.A. Istituto Ricerche Applicate at the address shown below. Do not use the device if skin shows signs of redness, swelling or pigmentation changes; do not use the device in the event of inflammation, infection or fever. Do not use in patients with ongoing infections or inflammatory conditions at or near the injection site. Do not use in patients taking anticoagulant medications (such as aspirin) as they may cause bruising or severe bleeding at the injection site. Do not use the device right after a laser treatment, chemical peel or dermabrasion, as this may cause an inflammatory reaction. Do not perform a laser treatment, chemical peel or dermabrasion after a treatment with the device until the side effects of the treatment have completely stopped.
• CW999

  ADVERSE REACTIONS Before starting treatment, the doctor must inform the patient that there are potential adverse reactions (side effects) related to the intradermal filler procedure. Some adverse reactions typical of hyaluronic acid products or the injection technique used may occur following the use of the device. From the clinical data available on the product, the following types of reactions may occur: - inflammatory reactions, redness, itching, pain to the touch after the injection, which generally resolve within a week; - bleeding or haematoma in rare cases; - acne papules that can form up to four weeks after treatment and have a duration of two weeks; - allergic reactions to hyaluronic acid; - hardening or the appearance of nodules at the injection site; - in very rare cases, granulomas or significant inflammatory reactions, welts or hives may appear, even after 2-4 weeks. - in very rare cases of administration errors, occlusions may occur, visible with an evident whitening of the treated area that evolves in increasingly severe conditions. In case of immediate swelling, it is useful to briefly apply cold compresses.
• CW999

  ADVERSE REACTIONS Treated users must report any type of reaction to the doctor who administered the product. The patient should be closely monitored for at least 30 minutes following the injection. The healthcare professional must advise the patient to seek medical attention if any adverse effects do not resolve on their own. The doctor, in addition to prescribing an appropriate treatment to treat these reactions, must inform the distributor and the manufacturer I.R.A. Istituto Ricerche Applicate S.p.A. using the email address medicaldevices@iralab.it In the event of a serious adverse reaction not listed in this information leaflet, the doctor must promptly inform the distributor, the manufacturer I.R.A. Istituto Ricerche Applicate S.p.A. using the email address medicaldevices@iralab.it and the pertaining authority of the Member State in which the user is established. INCOMPATIBILITY: there is a known incompatibility between hyaluronic acid and quaternary ammonium salts such as benzalkonium chloride. Therefore, avoid bringing the device into contact with such substances or using medical-surgical materials containing quaternary ammonium salts.
• CW999

  PRECAUTIONS Only use the device in accordance with these instructions for use. The device was packaged to be used on one patient only. Use the device immediately after opening the blister pack and discard the syringe immediately after use, even if the entire contents have not been used. The injection volume depends on the level of correction required and is at the doctor’s discretion. The notches on the syringe label only serve to guide the user. As a precautionary measure, a maximum dose per year of 24 mL is recommended. There is no evidence to support the use of doses greater than 24 mL of the device per 70 kg of body mass per year. It is recommended that physicians perform a test injection and observe the patient for at least 2 minutes to ensure that no acute allergic reaction occurs before proceeding with the main injection. Follow all normal precautions for use associated with intradermal injection procedures. The injection is linked to an inherent risk of infection, therefore the device is intended for use in a healthcare setting. Skin must be thoroughly cleansed and disinfected before treatment. The technique and depth of injection vary depending on the area to be treated. Never apply excessive pressure to the syringe. Delicate massage of the treated area promotes a homogeneous distribution of the product.Advise the patient to refrain from wearing make-up for 24 hours after the injection and inform them that, during the period of remission, or until swelling or redness has completely subsided, they should avoid exposing the treated area to direct sunlight, UV lamps or cold.
• CW999

  PRECAUTIONS In consultation with their doctor, patients on anticoagulant treatment should suspend the use of this medication for at least 14 days before receiving the device injections. No clinical data is available to support the use of the device before or after skin treatments with other dermal or intradermal products, until the possible side effects of the treatment have completely stopped. It is suggested to follow the precautions prescribed by guidelines and common clinical practice. After use, syringes and needles can pose a potential biohazard. Handle with care and dispose of in compliance with the disposal rules established by the local authority. When performing the injection procedure, there is a potential risk that the material may be inadvertently injected into the blood vessels. In rare cases this could cause vascular occlusion, abscess, necrosis or embolic phenomena, as amply described in literature. To check that the needle is not inside a blood vessel during normal use of the medical device, lightly aspirate with the syringe before the injection.
• CW999

  PRECAUTIONS Keep the product out of sight and reach of children. For more information on the safety and clinical performance of this medical device, a Summary of Safety and Clinical Performance (SSPC) is available on request, prepared pursuant to Article 32 of Regulation (EU) 2017/745. The summary is publicly available on the European database EUDAMED (https://ec.europa.eu/tools/eudamed/eudamed), using the UDI-DI identifier of the device or the trade name. The list of harmonized standards and common specifications applied to the device is available in the SSCP. Very important: before starting treatment, the doctor should inform the patient about the composition, characteristics, precautions for use, warnings, contraindications and potential adverse reactions associated with this device. In addition, the doctor should first check the patient's medical history, assess any previous immunological or allergic reactions they may have and ascertain whether the device is compatible for use. Finally, the doctor must evaluate the skin areas involved in the treatment, to ascertain the suitability of the patient for the filler procedure and the actual usefulness of the treatment. The device can only be administered by medical personnel qualified for the injection technique.

Primary placement in Italy; available across 15 countries total.

Trade name

not provided

UDI-DI code

D-HyamiraSoftHE

Basic UDI-DI

B-HyamiraSoftHE

Reference / catalog number

40371

Issuing entity

EUDAMED

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 1 MU48

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

D-HyamiraSoftHE

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES