BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISCERA RETAINER, FISH

    MDR report key: 533903 · Received July 7, 2004

    Report

    Report Number
    2918699-2004-00001
    Event Type
    Other
    Date Received
    July 7, 2004
    Report Date
    July 7, 2004
    Manufacturer
    ADEPT-MED INTL., INC.
    Product Code
    GCZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ABDOMINAL SURGERY TO REMOVE AN ADEPT-MED MEDICAL DEVICE I.E. A GLASSMAN VISCERA RETAINER, FISH, WHICH CONTRARY TO EXPRESS LABELING INSTRUCTIONS, WAS "INADVERTENTLY LEFT IN THEIR ABDOMEN" DURING A PREVIOUS ABDOMINAL SURGERY IN EITHER 1974, 1998 OR TWO SURGERIES IN 1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCERA RETAINER, FISH VISCERA RETAINER, FISH GCZ ADEPT-MED INTL., INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention