BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILITE AERO X

    MDR report key: 4048025 · Received August 7, 2014

    Report

    Report Number
    3032618-2014-00001
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 9, 2014
    Report Date
    August 6, 2014
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K072311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    END USER SAID HE GO OUT OF HIS BED AND INTO HIS WHEELCHAIR, AND IT BROKE IN HALF. HE SAID THAT HE FELL OVER, BUT MANAGED TO GET HIMSELF COLLECTED BACK UP. HE LOOKED AT THE DAMAGE TO THE CHAIR. HE SAID THE RIVET WAS BROKEN THAT HOLDS THE CROSS TUBES TOGETHER. HE SAID HE WAS A LITTLE SORE, BUT HE HAS BACK ISSUES, WITH A BULLET STILL IN HIS BACK. HE THOUGHT HE WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466149 TILITE AERO X WHEEL CHAIR, MECHANICAL IOR TISPORT, LLC AERO X

    Patients

    Seq Age Sex Outcome Treatment
    1