BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALTHLINE PVC MEDICAL PRODUCT

    MDR report key: 3838582 · Received May 21, 2014

    Report

    Report Number
    3838582
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    March 28, 2014
    Report Date
    May 20, 2014
    Manufacturer
    HEALTHLINE PVC PRODUCT
    Product Code
    INM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESIDENT WAS SITTING ON SHOWER TAXI COMMODE CHAIR IN THE SHOWER. CNA PULLED THE SHOWER CHAIR OUT OF THE SHOWER AND THE CHAIR BROKE, CAUSING THE RESIDENT TO FALL TO THE FLOOR. CHAIR IS OVER 10 YEARS OF AGE. A 400 POUND CAPACITY ON MANUFACTURING INFO. SUPPLIER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301176 HEALTHLINE PVC MEDICAL PRODUCT SHOWER TAXI COMMODE CHAIR INM HEALTHLINE PVC PRODUCT HLST603/OF/TF/SF/DA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR