BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIVERSAL

    MDR report key: 5397 · Received March 15, 1993

    Report

    Report Number
    5397
    Event Type
    Death
    Date Received
    March 15, 1993
    Date of Event
    February 2, 1993
    Report Date
    February 24, 1993
    Manufacturer
    EVEREST AND JENNINGS INC.
    Product Code
    KID
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS FOUND ON THE FLOOR OF HIS ROOM, IN HIS WHEELCHAIR. HE WAS RESTRAINED, RESTRAINT WAS STILLL INTACT, WHEELCHAIR WAS ON IT'S SIDE, AS WAS PATIENT. PATIENT SUSTAINED A FRACTURED SKULL. PATIENT WAS TRANSFERRED TO ROCKVILLE GENERAL HOSPITAL AND DIED SEVEN DAYS LATER.INVALID 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: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL NA KID EVEREST AND JENNINGS INC. 961032 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death