BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPLAST (VOLUME UNSPECIFIED)

    MDR report key: 665395 · Received January 17, 2006

    Report

    Report Number
    2024601-2006-00047
    Event Type
    Injury
    Date Received
    January 17, 2006
    Date of Event
    January 15, 2001
    Report Date
    December 20, 2005
    Manufacturer
    INAMED CORP (FREMONT)
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT DEVELOPED GENERALIZED FACIAL EDEMA AFTER TREATMENT WITH ZYPLAST. THE EDEMA HAS PERSISTED FOR FOUR YEARS. THE PT HAS BEEN ON ORAL MEDROL DOSE PAK ONCE OR TWICE A MONTH FOR FOUR YEARS TO TREAT THE EDEMA. THE REPORTER IS NOT THE ORIGINAL TREATING PHYSICIAN AND DOES NOT HAVE TREATMENT INFO FOR THIS CASE. SYMPTOM DURATION HAS EXCEEDED TWO YEARS. PURSUANT TO AN AGREEMENT BETWEEN FDA AND COLLAGEN CORP ANY SYMPTOMS THOUGHT TO BE RELATED TO HYPERSENSITIVITY TO BOVINE COLLAGEN THAT LAST LONGER THAN TWO YEARS WOULD BE REPORTED AS A PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYPLAST (VOLUME UNSPECIFIED) INJECTABLE COLLAGEN IMPLANT LMH INAMED CORP (FREMONT) NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R