Volomis SOFT

Organization name

Dermoaroma Italy srl

SRN

IT-MF-000034895

Manufacturer status

Active

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

• CW999

  Contraindications: 1) Use of Dermal Filler in patients exhibiting autoimmune connective tissue disease is not recommended. Dermal Filler is contraindicated in infected or non - vascular surgical sites, unless specifically prescribed by their physician. 2) Patients should avoid non-steroidal anti- inflammatory drugs, including Aspirin®, for the two weeks preceding the treatment with Volomis. 3) Ancillary agents that may cause inflammation at the treatment site should be avoided. 4) Dermal Filler should not be used in periocular line correction or glabellar contouring. 5) Do not apply it to the following patients: patients who have been given aggregation inhibitors, anticoagulants, immunosuppressive medications, etc. 6) Do no apply to the patients with allergic disease, autoimmune disease, sarcoid granulomatous diseases, and Osler's endarteritis. 7) Do not use in patient using pacemaker or active implantable medical devices for suggestions and tensions during the treatment. 8) Do not apply to the pregnant and lactating women. 9) Do not apply to the infants and juveniles.
• CW999

  General warnings: 1) Do not apply the product to locations that have been treated by fillers lately or by fillers not reabsorbed. 2) Do not apply it to the other locations (breast, for example) besides the face. 3) Do not inject it into tendons, muscles, or bones. 4) Do not inject it into blood vessel. 5) Do not overuse. 6) Do not apply it to people who have a hypersensitivity to the ingredient of the product (Hyaluronic acid). 7) Do not apply it to inflammatory or infected skins. 8) Do not use it in combination with laser, chemical peeling or skin scraping treatment. 9) Long term safety and effectiveness of Dermal Filler beyond 6 months have not been investigated in clinical trials. 10) Re-administration interval of Dermal Filler is recommended about 6 months. 11) Appearance of a product should be checked before use and if it is with any abnormality, it should not be used. 12) When injecting to the patient, apply force slowly and uniformly to the plunger rod.
• CW011

  EUDAMED did not publish a description for this code.
• CW010

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

  EUDAMED did not publish a description for this code.
• CW001

  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.
• CW999

  Safety information: The medical device must be used by trained physicians (experts trained who can use this medical device) only, in an operating room or at a clean room of hospital.
• CW999

  Precautions: 1) Dermal Filler is packaged for single patient use. 2) As with all transcutaneous procedures, Volomis implantation carries a risk of infection. 3) Dermal Filler implants should be not used in patients on immunosuppressive therapy. 4) The safety and effectiveness of Dermal Filler implantation for use in lip augmentation has not been established. 5) No long-term studies have been conducted to evaluate the potential of Dermal Filler to cause cancer. Potential risks to an embryo or fetus are unknown at this time and there may be other risks or side effects that are also unknown at this time. 6) In case of the product that includes needle, use the needle provided with the product. 7) In case of the product that does not include needle, the qualified doctor can select and use the needle gauge that fits the filler (recommended needles: 23 G normal wall needle, 25 G extra thin wall needle, 20 G – 30 G cannula).

Primary placement in Italy; available across 3 countries total.

Trade name

not provided

UDI-DI code

08056585950546

Basic UDI-DI

B-08056585950546

Reference / catalog number

Volomis SOFT

Issuing entity

GS1

Risk category

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

1ml syringe, individually packed in lidded blister, box of 3 units with needles.

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

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

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES