BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 2 COLLAGEN IMPLANT (0.5ML)

    MDR report key: 2120257 · Received June 7, 2011

    Report

    Report Number
    2024601-2011-00468
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    October 12, 2004
    Report Date
    May 12, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LMH
    PMA / PMN Number
    P800022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTED AS: AFTER INJECTION OF ZYDERM IN THE NASOLABIAL FOLDS, LIPS AND GLABELLA, THE PT EXPERIENCED SYMPTOMS OF INFLAMMATION, NODULES AND PRURITUS AROUND THE INJECTION SITES. THE PT WAS PRESCRIBED AN INJECTION OF TRIAMHEXAL 20 AND STEROIDS. IT IS UNK HOW THE STEROIDS WAS ADMINISTERED. THE ADVERSE EVENTS HAVE PARTIALLY RESOLVED. THE PT WAS TREATED WITH ZYDERM 1 AND ZYDERM 2. IT IS NOT KNOWN WHERE EACH PRODUCT WAS USED FOR TREATMENT. THIS REPORT WAS CREATED FOR THE ZYDERM 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 2 COLLAGEN IMPLANT (0.5ML) LMH ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention