BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREX WEIGHT CAPACITY 300 LB SHOWER STOOL

    MDR report key: 8760625 · Received July 2, 2019

    Report

    Report Number
    MW5087874
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 1, 2019
    Manufacturer
    COM-DA HEALTHCARE CO. LTD / REGULATORY INSIGHT INC.
    Product Code
    ILS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SITTING ON HOME HEALTH SUPPLIED SHOWER CHAIR IN SHOWER, SOAPING WASHCLOTH WHEN CHAIR LEG COLLAPSED, FELL TO FLOOR AND UNABLE TO GET UP. AM 12 WEEKS OUT FROM POSTERIOR APPROACH RIGHT HIP REPLACEMENT. WIFE DRUG ME TO BEDROOM AND HAD TO CALL AMBULANCE TO GET OFF THE FLOOR. BRUISED LEFT HIP. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546080 CAREX WEIGHT CAPACITY 300 LB SHOWER STOOL ADAPTOR, HYGIENE ILS COM-DA HEALTHCARE CO. LTD / REGULATORY INSIGHT INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention