BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE TOURNIQUET CUFF

    MDR report key: 5960 · Received February 12, 1993

    Report

    Report Number
    1020279-1993-00001
    Event Type
    Injury
    Date Received
    February 12, 1993
    Report Date
    January 5, 1993
    Manufacturer
    INSTRUMED, INC.
    Product Code
    GAX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    SURGERY WAS PERFORMED ON THE PATIENT USING THE DEVICE ON THE PATIENT'S LEG. THE PATIENT'S LEG LATER COMPARTMENTALIZED THUS CAUSING DAMAGE TOTHE LEG. THE PATIENT WAS IN CRITICAL CONDITION, BUT IS REPORTED TO BE DOING FINE NOW. THE SURGEON HAS REPORTED THAT THE CUFF CAUSED A WEAK PRESURE POINT ON THE PATIENT'S LEG. THIS DEVICE WAS BEING USED IN CONJUNCTION W/THE ATS 500 TOURNIQUET SYSTEM (ZIMMER)INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE TOURNIQUET CUFF TOURNIQUET CUFF GAX INSTRUMED, INC. N/A 156246

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention