BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYDERM 1 COLLAGEN IMPLANT (0.5ML)

    MDR report key: 735748 · Received July 12, 2006

    Report

    Report Number
    2024601-2006-00422
    Event Type
    Injury
    Date Received
    July 12, 2006
    Date of Event
    June 11, 2006
    Report Date
    June 12, 2006
    Manufacturer
    INAMED CORPORATION (FREMONT)
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTED AS "0.5 MLS Z1 IMPLANTED BOTH UPPER CHEEKS FOR FIE LINES BELOW ORBITAL RING. BECAME RED, ITCHY AND SWOLLEN NEXT DAY." ORAL PREDNISONE AND PHENERGAN WERE PRESCRIBED TO TREAT THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 1 COLLAGEN IMPLANT (0.5ML) INJECTABLE COLLAGEN IMPLANT LMH INAMED CORPORATION (FREMONT) 0914 05A011G

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention