BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSENTIAL BATH SAFETY

    MDR report key: 5775130 · Received July 7, 2016

    Report

    Report Number
    1056127-2016-00005
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    May 24, 2016
    Report Date
    June 13, 2016
    Manufacturer
    HOMECARE ENTERPRISE CO. LTD.
    Product Code
    ILS
    UDI-DI
    00754756140243
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER WAS SEATED IN THE SHOWER WHEN THIS BATH STOOL COLLAPSED. THE UPPER FRAME BROKE IN THE MIDDLE. PATIENT FELL BUT DID NOT SUFFER ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429201 ESSENTIAL BATH SAFETY BATH STOOL ILS HOMECARE ENTERPRISE CO. LTD. 5053S N/A 00754756140243

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR