BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 2 COLLAGEN IMPLANT (1.0ML)

    MDR report key: 1153231 · Received September 8, 2008

    Report

    Report Number
    2024601-2008-00580
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 15, 2008
    Manufacturer
    INAMED CORP. (FREMONT)
    Product Code
    LMH
    PMA / PMN Number
    P800022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 9/8/2008. DEVICE EVAL SUMMARY: WE HAVE REVIEWED THE DEVICE HISTORY RECORDS FOR THIS LOT FROM FINISHED PRODUCT LABELING TO THE HIDE BATCH. ALL STERILITY, BIOBURDEN, PYROGEN (RABBIT) AND LAL TESTING WAS PERFORMED AS REQUIRED AND ALL TESTS PASSED. DURING REVIEW OF THE DEVICE HISTORY RECORDS, A MINOR DEVIATION WAS NOTED. THE DEVIATION NOTED WAS NOT SIGNIFICANT NOR WOULD CONTRIBUTE TO A CAUSE FOR THIS COMPLAINT. BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS, WE FIND NO ASSIGNABLE CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IMMEDIATELY AFTER TREATMENT WITH ZYDERM 2 IN THE CHIN THE PT PRESENTED WITH A NODULE IN THE CHIN AND SWELLING ON BOTH SIDES OF THE CHIN. THE PHYSICIAN PRESCRIBED KENALOG FOR THE NODULE AND SWELLING, BUT THE SYMPTOMS HAVE NOT RESOLVED. THE PT HAD A COLLAGEN SKIN TEST PERFORMED ONE WEEK BEFORE TREATMENT. THE PT HAS HAD PRIOR HISTORY WITH ZYDERM AND IS ALLERGIC TO SULFA. THE PT IS CURRENTLY TAKING HORMONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 2 COLLAGEN IMPLANT (1.0ML) INJECTABLE COLLAGEN IMPLANT LMH INAMED CORP. (FREMONT) NA 06B011B

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention FEMALE HORMONES