BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON

    MDR report key: 405824 · Received July 17, 2002

    Report

    Report Number
    MW1025612
    Event Type
    Other
    Date Received
    July 17, 2002
    Report Date
    July 17, 2002
    Manufacturer
    ETHICON ENDO-SURGERY, INC. J & J CO
    Product Code
    GDT
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OB/GYN PHYSICIAN REPORTED 4 CASES WHERE STAPLES CAME OFF ON POST-OP DAY 1-2. IN 2 CASES, THE STAPLES DETACHED FROM THE SKIN WITH REMOVAL OF THE BANDAGE. IN ONE CASE, THE 2 STAPLES CAME OFF AFTER THE PT HAD AN EPISODE OF COUGHING AND IN THE LAST CASE, ONE STAPLE CAME OFF AFTER THE PT VOMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON SKIN STAPLER-NOVAPLUS PROXIMATE PLUS MD 35 GDT ETHICON ENDO-SURGERY, INC. J & J CO NOAPLUS PROXIMATE PLUS MD 35 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other