BEUDAMED
    FDA Adverse Event Other Summary report: N

    RETRACTOR, PELVIC SITE

    MDR report key: 386247 · Received April 5, 2002

    Report

    Report Number
    1221601-2002-00008
    Event Type
    Other
    Date Received
    April 5, 2002
    Date of Event
    March 14, 2002
    Report Date
    April 5, 2002
    Manufacturer
    GENZYME BIOSURGERY A DIVISION OF GENZYME
    Product Code
    FDG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LIGHT PANEL, PRODUCT CODE 89-9501, WAS ALLEGED TO BE MELTING AT THE BEND WHILE ON THE RETRCTOR, PRODUCT CODE 89-9500. ADD'L INFO REC'D IN 2002 REVEALED THE COMPLAINANT WAS UNAWARE OF ANY PT INJURIES RESULTING FROM THE MELTED LIGHT PANELS. THE COMPLAINANT WAS UNABLE TO PROVIDE ANY LIGHT PANEL LOT INFORMATION NOR ANY ADD'L EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETRACTOR, PELVIC SITE RETRACTOR FDG GENZYME BIOSURGERY A DIVISION OF GENZYME 89-9500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other