BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 SERIES

    MDR report key: 5260905 · Received November 27, 2015

    Report

    Report Number
    1834066-2015-00002
    Event Type
    Malfunction
    Date Received
    November 27, 2015
    Date of Event
    October 18, 2015
    Report Date
    November 24, 2015
    Manufacturer
    CHAMPION MFG. INC.
    Product Code
    FRJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS WAS AN UNOBSERVED FALL. PATIENT FOUND FACE DOWN ON THE FLOOR WITH RECLINER ON TOP OF HIM. PATIENT HAD A SKIN TEAR ON HIS HEAD. A CT SCAN WAS DONE. MEDICAL TREATMENT CONSISTED OF CLEANING THE TEAR AND WRAPPING WITH GAUZE. UNKNOWN IF THE PATIENT WAS IN THE CHAIR AT THE TIME THAT HE FELL OR IF HE FELL AND TRIED TO RIGHT HIMSELF AFTER FALLING BY PULLING ON THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783151 54 SERIES STANDARD MEDICAL RECLINER FRJ CHAMPION MFG. INC. 547T09-73

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR