BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZRA

    MDR report key: 8571403 · Received May 1, 2019

    Report

    Report Number
    3032618-2019-00004
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    April 2, 2019
    Report Date
    May 1, 2019
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE REVIEWED THE DHR FOR THIS CHAIR, AND IT PASSED ALL APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS, AND MET SPECIFICATIONS AS ORDERED BY THE DEALER WHEN IT LEFT THE FACILITY. THE DEALER AND/OR A THERAPIST MEASURED THE USER FOR A WHEELCHAIR. TISPORT AS THE MANUFACTURER BUILDS THE CHAIR BASED ON THE MEASUREMENTS PROVIDED TO US FROM THE DEALER AND/OR THERAPIST. ALL DOCUMENTATION AND SPECIFICATIONS FOR THE CHAIR WERE APPROPRIATELY DISSEMINATED TO THE HEALTH SPECIALIST WORKING WITH THE END USER. THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE EVIDENCE PROVIDED, THE FRACTURE IN THE BACKREST BRACKET IS LIKELY THE RESULT OF EXCESSIVE FORCES INTRODUCED TO THE BACKREST ASSEMBLY THROUGH IMPACT OR ABUSE. IF MORE INFORMATION IS PROVIDED THAT CHANGES THE CONCLUSIONS OF THE INVESTIGATION, A FOLLOW UP MEDWATCH FORM 3500A WILL BE FILED.

    Description of Event or Problem · 1

    THE END USER ALLEGES THAT WHILE PUTTING ON HIS PANTS IN THE BATHROOM, THE BACKREST HINGES FRACTURED, RESULTING IN LIGAMENT DAMAGE IN HIS ARM. HE IS IN A FULL ARM CAST, AND WILL RECEIVE INJECTIONS IN HIS ARM AS TREATMENT WITH THE POSSIBILITY OF SURGERY FOR FUTURE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363028 ZRA WHEELCHAIR IOR TISPORT, LLC ZRA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention