BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABDOMINAL PACK

    MDR report key: 178773 · Received July 27, 1998

    Report

    Report Number
    1423507-1998-00238
    Event Type
    Other
    Date Received
    July 27, 1998
    Date of Event
    June 16, 1998
    Report Date
    July 27, 1998
    Manufacturer
    ALLEGIANCE HEALTHCARE CORPORATION
    Product Code
    FRL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ADHESIVE IS MISSING OR COMES OFF IN A SMALL WAD FROM BOVIE SCRATCH PAD. JULY 16, 1998 RECEIVED A SECOND PQR (1998-005813) GIVING ADDITIONAL INFORMATION: TELEPHONE CONVERSATION WITH REPORTER CONFIRMS THAT THE FOLLOWING REPORT HAPPENED ONLY ONCE AND THAT ALLEGIANCE WAS NOT NOTIFIED OF THE ADDITIONAL INFORMATION UNTIL JULY 14, 1998. BOVIE SCRATCH PADS ARE DEFECTIVE. ADHESIVE MISSING OR COMES OFF IN SMALL WADS. UNABLE TO USE. PAD GOT INSIDE PATIENT UNKOWN TO ALL UNTIL IT WAS ACCIDENTALLY RETREIVED WITH LAP SPONGES. NO X-RAYS OR ADDITIONAL MEDICATION WAS REQUIRED. THE PIECE OF THE BOVIE PAD WAS FOUND AT THE END OF THE PROCEDURE WHEN THE SURGEON WAS READY TO CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABDOMINAL PACK ABDOMINAL PACK FRL ALLEGIANCE HEALTHCARE CORPORATION SMA34AHMMF 292076

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other