BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPA SAFETY SERIES DRIVE PREMIUM SHOWER CHAIR WITH FOLDING BACK

    MDR report key: 9750281 · Received February 24, 2020

    Report

    Report Number
    MW5093232
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    February 11, 2020
    Report Date
    February 20, 2020
    Manufacturer
    DRIVE - DEVILBISS HEALTHCARE / COLUMBIA MEDICAL, LLC
    Product Code
    ILS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USING SPA FOLDING BACK SHOWER CHAIR, ITEM # BRTL 12606-AST, THE LEGS COLLAPSED. I FELL IN THE SHOWER, 911 WAS CALLED BY WIFE. THE 911 RESPONDENTS ELEVATED ME INTO THE AMBULANCE FOR A TRIP TO (B)(6) HOSP ER. HAD CAT SCAN, AFTER 4 HOURS IN ER RELEASED WITH MEDICAL REPORT. CONTACTED MFR ON 02/18/2020. THEY PROMISED A SAME DAY RESPONSE WHICH HAS NOT OCCURRED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211485 SPA SAFETY SERIES DRIVE PREMIUM SHOWER CHAIR WITH FOLDING BACK ADAPTOR, HYGIENE ILS DRIVE - DEVILBISS HEALTHCARE / COLUMBIA MEDICAL, LLC #BRTL 12606-AST

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R