BEUDAMED
    FDA Adverse Event Summary report: N

    DISPOSABLE SKIN STAPLER

    MDR report key: 16561 · Received May 31, 1994

    Report

    Report Number
    MW4000487
    Date Received
    May 31, 1994
    Report Date
    May 31, 1994
    Manufacturer
    RICHARD-ALLAN MEDICAL INDUSTRY, INC.
    Product Code
    GDT
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    GENERAL SURGEONS TRIED THE STAPLER AND FELT THAT IT WAS NOT AN ACCEPTABLE PRODUCT. THEY REMOVED STAPLER FROM FIELD AND REQUESTED A DIFFERENT PRODUCT. STAPLES DID NOT HOLD DRAPES DID NOT HOLD DRAPES PROPERLY AND WERE POOR QUALITY. DID NOT WANT TO USE ON SKIN IF IT WOULD NOT HOLD DRAPES. A 3RD DR MENTIONED HE HAD HAD THE SAME PROBLEM ON AN EARLIER CASE WITH THE SAME TYPE STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SKIN STAPLER GDT RICHARD-ALLAN MEDICAL INDUSTRY, INC. 93E08

    Patients

    Seq Age Sex Outcome Treatment
    1 *