BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 1099 · Received August 18, 1992

    Report

    Report Number
    1099
    Event Type
    Injury
    Date Received
    August 18, 1992
    Date of Event
    July 9, 1992
    Report Date
    July 24, 1992
    Manufacturer
    AM-FAB
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RESIDENT LEANED ON SIDE RAIL AND SIDE RAIL FELL AND RESIDENT FELL OUT OF BED. RESIDENT SUSTAINED LACERATION ON FOREHEADDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUL-92. 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A ELECTRIC BED FNL AM-FAB N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention