BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAZ DESIGN INC.

    MDR report key: 7381033 · Received March 29, 2018

    Report

    Report Number
    3006055387-2018-00002
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    March 20, 2017
    Report Date
    March 22, 2018
    Manufacturer
    RAZ DESIGN INC.
    Product Code
    INN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT / CLIENT CLAIMS THAT THE SEAT DID NOT SUPPORT HIM AS INTENDED WHICH RESULTED IN HIS INJURIES SUSTAINED DUE TO IMPACT WITH FRONT SEAT SUPPORT TUBE. IT IS OUR BELIEF THAT THE USER / CAREGIVER FAILED TO LATCH THE FRONT SEAT BRACKETS AND THIS ALLOWED THE SEAT TO SLIDE FORWARD AND DETACH FROM THE CHAIR. THROUGH ANALYSIS PERFORMED BY MR. (B)(6), WITH THE BRACKETS MOUNTED IN THE PROPER POSITION, NELSON WAS UNABLE TO REPLICATE JOHNSON'S ACCOUNT OF THE ACCIDENT THAT HE SLIPPED "INTO THE HOLE, IN THE SLOT THAT'S IN THE HOLE" AND "I HEARD, LIKE, A CRACK AND THE SEAT WAS SITTING NEXT TO ME AND I WAS ON TOP OF THE BAR THAT WAS UNDERNEATH THE SEAT." RAZ'S INSURANCE COMPANY HAS RETAINED AN EXPERT FORENSIC ENGINEER WHO WILL BE CONDUCTING ADDITIONAL TESTING ON AN IDENTICALLY CONFIGURED CHAIR.

    Description of Event or Problem · 1

    THE CLIENT REPORTED THAT HE WAS SITTING IN THE CHAIR IN THE SHOWER WHEN THE SEAT SLID FORWARD AND HE FELL INTO THE CHAIR, WHICH CAUSED AN INJURY. IT IS OUR BELIEF THAT THE USER / CAREGIVER FAILED TO LATCH THE FRONT SEAT BRACKETS AND THIS ALLOWED THE SEAT TO SLIDE FORWARD AND DETACH FROM THE CHAIR FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223989 RAZ DESIGN INC. RAZ-SP (SELF PROPEL SHOWER COMMODE CHAIR) INN RAZ DESIGN INC. Z200

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R