BEUDAMED
    FDA Adverse Event Summary report: N

    ARGYLE VASCULAR TOURNIQUET KIT

    MDR report key: 35326 · Received July 24, 1996

    Report

    Report Number
    35326
    Date Received
    July 24, 1996
    Report Date
    February 28, 1996
    Manufacturer
    SHERWOOD MEDICAL CO.
    Product Code
    KCY
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING OPEN HEART SURGERY, THE TIP OF THE PLASTIC INSERT BROKE OFF DURING CANNULATION OF THE HEART. THE PIECE WAS UNABLE TO BE LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGYLE VASCULAR TOURNIQUET KIT TOURNIQUET KCY SHERWOOD MEDICAL CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA