PV00016

Organization name

i+Med S.Coop.

SRN

ES-MF-000008633

Manufacturer status

Active

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

• CW010

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

  SINGLE USE PRODUCT.
• CW001

  DO NOT RE-STERILISE, since re-sterilization may affect the physico-chemical properties of the product and compromise its efficacy and security.
• CW007

  The product should not be used if the package is damaged or broken.
• CW032

  The product should not be used after the expiration date.
• CW135

  Pediatric use: since the safety of this product has not been established in children, special care should be paid if the product is used in children. KEEP OUT OF THE REACH OF CHILDREN.
• CW276

  Do not use with other products containing quaternary ammonium salts because sodium hyaluronate can precipitate in their presence. In order to prevent any possible interaction avoid the simultaneous administration with other intra-articular products.
• CW161

  TrHLINE has not been tested in pregnant women: special care should be paid if the product is used in pregnant or lactating women. It is recommended to discontinue breastfeeding during treatment.
• CW999

  Do not administer to patients with known hypersensitivity (allergy) to hyaluronate preparations and in the case of infections or skin diseases in the area of the injection site. The use of TrHLINE in any other joints besides the knee and for other conditions such as radiographic OA or any non-OA causes of joint pain is not indicated. Use in the elderly: the product must be administered with caution, since physiological functions are usually reduced in these patients. Do not inject in patients with bleeding disorders, liver diseases and/or venous or lymphatic stasis. The product must be injected strictly into the intra-articular space otherwise it may cause pain. Do not inject into a blood vessel or surrounding tissues. Do not inject in inflamed joints, the product must be administered after the local symptom has been alleviated. To avoid pain after the injection, it should be recommended to keep the injection site in relative rest for 48 hours after the injection. It is recommended that the patient avoids any strenuous physical activities or prolonged (i. e., more than one hour) weight-bearing activities within 48 hours following the intra-articular injection. STRICT ASEPTIC PROCEDURE SHOULD BE FOLLOWED. CE marked and Luer-lock fittings accessories (needles) must be used.

Primary placement in Spain; available across 1 country total.

Trade name

not provided

UDI-DI code

08437015992006

Basic UDI-DI

B-08437015992006

Reference / catalog number

PV00016

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

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2 MU48

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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