BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESIDENT RELEASE BED BELT

    MDR report key: 8241 · Received May 18, 1994

    Report

    Report Number
    8241
    Event Type
    Injury
    Date Received
    May 18, 1994
    Date of Event
    May 11, 1994
    Manufacturer
    SKIL-CARE CORP.
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS BEING USED IN A CHAIR, RATHER THAN A BED, AS A REMINDER FOR RESIDENT NOT TO AMBULATE UNASSISTED. THREADS HOLDING A SEAM DID NOT HOLD AND RESIDENT WAS ABLE TO RISE WITHOUT RELEASING THE BELT. THE RESIDENT WALKED A SHORT DISTANCE AND THEN FELL. SUBSEQUENT X-RAYS REVEALED THAT THE RESIDENT SUSTAINED A FRACTURE OF LUMBAR VERTEBRA #1.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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 NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INADEQUATE QUALITY ASSURANCE, NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESIDENT RELEASE BED BELT QUICK RELEASE BELT FMQ SKIL-CARE CORP. 610410

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention