BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSENTIAL BATH SAFETY SHOWER BENCH

    MDR report key: 4541762 · Received February 20, 2015

    Report

    Report Number
    1056127-2015-00005
    Event Type
    Malfunction
    Date Received
    February 20, 2015
    Date of Event
    January 31, 2015
    Report Date
    February 2, 2015
    Manufacturer
    HOMECARE ENTERPRISE CO. LTD.
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER SHOWERING THE PATIENT PICKED UP SHOWER BENCH AND PLACED IT OUTSIDE THE SHOWER ON A RUG. THE PATIENT SAT DOWN TO DRY HIMSELF OFF AND A REAR LEG BENT INWARD CAUSING HIM TO FALL AND SPRAIN A FINGER. NO MEDICAL ATTENTION WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122707 ESSENTIAL BATH SAFETY SHOWER BENCH SHOWER BENCH ILS HOMECARE ENTERPRISE CO. LTD. 5042

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR