BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAFETY VEST

    MDR report key: 1412 · Received September 22, 1992

    Report

    Report Number
    1412
    Event Type
    Death
    Date Received
    September 22, 1992
    Date of Event
    June 16, 1992
    Report Date
    September 9, 1992
    Manufacturer
    J.T. POSEY COMPANY
    Product Code
    BRT
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RESIDENT FOUND AT BEDSIDE WITH POSEY VEST RESTRAINT BELT WRAPPED AROUND HER NECK. WAS TRANSFERRED TO THE HOSPITAL AND PRONOUNCED DEAD. INCIDENT CALLED INTO MICHIGAN DEPARTMENT OF PUBLIC HEALTH ( COMPLAINT # A-92-0884)AND ATTORNEY GENERALS OFFICEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. 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. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: STORAGE/SHIPMENT, FAILURE TO FOLLOW INSTRUCTIONS, INCORRECT TECHNIQUE/PROCEDURE, MISAPPLICATION OF DEVICE. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY VEST POSEY RESTRAINT BRT J.T. POSEY COMPANY 3331 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death