BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER, INC.

    MDR report key: 1511 · Received October 8, 1992

    Report

    Report Number
    32966-1992-00008
    Event Type
    Injury
    Date Received
    October 8, 1992
    Date of Event
    August 5, 1992
    Report Date
    September 29, 1992
    Manufacturer
    ZIMMER, INC.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD TREATMENT FOR RADIAL TUNNEL SYNDROME IN WHICH ATS 1500 TOURNIQUET WAS USED. WHEN PATIENT RETURNED FOR FOLLOW-UP VISIT THE FOLLOW-UP VISIT THE FOLLOWING DAY THERE WAS A MARK ON HER ARM WHERE THE TOURNIQUET CUFF HAD BEEN PLACED. HOSPITAL IS POSSIBLY SENDING THE UNIT TO AN INDEPENDENT TESTING CENTER TO SEE IF UNIT IS DEFECTIVEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER, INC. TOURNIQUET JOW ZIMMER, INC. A.T.S. 1500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention