BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER LIFT

    MDR report key: 558 · Received April 24, 1992

    Report

    Report Number
    558
    Event Type
    Malfunction
    Date Received
    April 24, 1992
    Report Date
    April 17, 1992
    Manufacturer
    TED HOYER & COMPANY
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE ALLEDGED INCIDENT OCCURRED ON APRIL 14, 1992 AND IONVOLVED A PATIENT WHO RECEIVED A FRACTURED LEG WHEN A RING ON A HOYER LIFT BROKE AND PATIENT FELL TO FLOORINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT PATIENT LIFT FNG TED HOYER & COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other