BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWERS MANDIBULAR GLOVE

    MDR report key: 356714 · Received October 16, 2001

    Report

    Report Number
    2028924-2001-00006
    Event Type
    Injury
    Date Received
    October 16, 2001
    Date of Event
    September 1, 2001
    Report Date
    October 11, 2001
    Manufacturer
    IMPLANTECH ASSOCIATES INC.
    Product Code
    FWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    POST-OP INFECTION. SURGERY DATE 2001. PT DEVELOPED INFECTION. DR. CONCERNED THAT THIS IS THE SECOND POST-OP INFECTION AFTER IMPLANTING FMG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46437 FLOWERS MANDIBULAR GLOVE SILICONE FACIAL IMPLANT FWP IMPLANTECH ASSOCIATES INC. * 603873

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention