BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHERWOOD G-BUTTON

    MDR report key: 35258 · Received July 17, 1996

    Report

    Report Number
    35258
    Event Type
    Other
    Date Received
    July 17, 1996
    Date of Event
    April 30, 1996
    Report Date
    May 9, 1996
    Manufacturer
    SHERWOOD MEDICAL CO.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROTOTYPE BUTTON FOUND TO BE ENTRAPPED IN GASTRIC WALL. VIA EGD, BUTTON BASE DISLODGED FROM WALL, TURNED 1/4. WILL MONITOR ON OUTPATIENT BASIS. THIS DEVICE WAS NOT IMPLANTED AT FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHERWOOD G-BUTTON PEG KNT SHERWOOD MEDICAL CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other