BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BED, WITH SIDE RAIL

    MDR report key: 611 · Received May 25, 1992

    Report

    Report Number
    611
    Event Type
    Injury
    Date Received
    May 25, 1992
    Date of Event
    May 2, 1992
    Report Date
    May 6, 1992
    Manufacturer
    LUMEX, INC.
    Product Code
    FNK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS FOUND LYING ON RIGHT SIDE WITH (R) FOOT AND LEG EXTENDED THROUGH SIDE RAIL. WHEN REPOSITION (R) LEG AND FOOT ABDUCTED AND ROTATED. UPPER (R) EXTREMITY EDEMATOUS, TOES CYANOTIC. X-RAY REVEALED FX. (R) HIPINVALID 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED, WITH SIDE RAIL FNK LUMEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention