BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD PRESSURE SPHYGMOMANOMETER

    MDR report key: 7256 · Received November 5, 1993

    Report

    Report Number
    1450057-1993-00193
    Event Type
    Injury
    Date Received
    November 5, 1993
    Date of Event
    October 21, 1993
    Report Date
    November 3, 1993
    Manufacturer
    SUZUKEN CO, LTD.
    Product Code
    DXN
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED ON 10/21/93 THAT AN INCIDENT OCCURRED INVOLVING A WALL MOUNTED LARGE FACE SPHYGMOMANOMETER WHICH ALLEGEDLY FELL OFF THE WALL AND HIT A PATIENT LYING IN THE BED BELOW THE SPHYGMOMANOMETER IN THE HEAD. THE BLOW RESULTED IN A FEW STICTHES.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING 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. 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: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD PRESSURE SPHYGMOMANOMETER DXN SUZUKEN CO, LTD. 530202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention