BEUDAMED
    FDA Adverse Event Summary report: N

    BATHING AND SHOWER SEAT

    MDR report key: 9569394 · Received January 8, 2020

    Report

    Report Number
    MW5092118
    Date Received
    January 8, 2020
    Date of Event
    November 22, 2019
    Report Date
    January 8, 2020
    Manufacturer
    AQUASENSE / MEDICAL DEPOT, INC., DBA DRIVE DEVILBISS HEALTHCARE/COLUMBIA MEDICAL, LLC
    Product Code
    ILS
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY MOTHER WAS BEING BATHED AND WAS SEATED IN HER AQUA SENSE FOLDABLE BATH AND SHOWER SEAT. HER CAREGIVER WAS WASHING HER HAIR, WHEN THE BACK OF THE SEAT SPONTANEOUSLY BROKE OFF. MY MOM THEN FELL BACKWARDS IN THE BATHTUB, RESULTING IN A TWO INCH LACERATION ON THE BACK. I HAVE THE PRODUCT TO PROVE THAT IT BROKE AND I EMAILED THE COMPANY. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29601 BATHING AND SHOWER SEAT ADAPTOR, HYGIENE ILS AQUASENSE / MEDICAL DEPOT, INC., DBA DRIVE DEVILBISS HEALTHCARE/COLUMBIA MEDICAL, LLC 770-525

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR