BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYDERM 2 COLLEGEN IMPLANT (VOLUME UNSPECIFIED)

    MDR report key: 623589 · Received July 28, 2005

    Report

    Report Number
    2024601-2005-00451
    Event Type
    Other
    Date Received
    July 28, 2005
    Date of Event
    May 1, 2005
    Report Date
    June 30, 2005
    Manufacturer
    INAMED CORPORATION (FREMONT)
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INJECTED WITH ZYDERM 1 & 2 SIX YEARS AGO - TWO TO THE THREE MONTHS AGO NASOLABIALS STARTED TO FEEL SOLID WITH BLUEISH DISCOLOURATION, NODULES ON BOTH SIDES OF UPPER LIPS. SYMPTOM DURATION HAS EXCEEDED TWO YEARS. PURSUANT TO AN AGREEMENT BETWEEN FDA AND COLLEGEN CORPORATION ANY SYMPTOMS THOUGHT TO BE RELATED TO HYPERSENSITIVITY TO BOVINE COLLAGEN THAT LAST LONGER THAN TWO YEARS WOULD BE REPORTED AS A PERMANENT INJURY. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID # 2024601-2005-00451 (INAMED COMPLAINT #2081853). FOR THE SECOND SUSPECT PRODUCT, ALSO A DEVICE MANUFACTURER BY INAMED CORPORATION. THIS SEPARATE DISTINCT NUMBER IS PROVIDED PER THE FDA'S REQUEST FOR TRACEABILITY PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 2 COLLEGEN IMPLANT (VOLUME UNSPECIFIED) INJECTABLE COLLAGEN IMPLANT LMH INAMED CORPORATION (FREMONT) NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other