BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TR

    MDR report key: 11675647 · Received April 15, 2021

    Report

    Report Number
    3032618-2021-00003
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Report Date
    April 15, 2021
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CLAIMS THAT THE USER'S ANTI-TIP DEVICE BROKE AND THAT THE USER FELL AND RECEIVED A HEAD INJURY. THE REPORTER DID NOT SPECIFY THE SEVERITY OF THE INJURY OR IF MEDICAL ATTENTION WAS SOUGHT. ATTEMPTS TO CONTACT THE REPORTER FOR MORE INFORMATION WERE UNSUCCESSFUL. TILITE REQUESTED RETURN OF FAILED PART BUT NO RESPONSE WAS RECEIVED. THE DHR FOR THE CHAIR WAS REVIEWED AND THE CHAIR PASSED ALL APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS. IT MET ALL MANUFACTURER SPECIFICATIONS WHEN IT LEFT THE FACILITY. WITHOUT THE ABILITY TO EVALUATE THE DEVICE, IT IS DIFFICULT TO DETERMINE THE CAUSE OF FAILURE. AT THIS TIME, THE CAUSE IS UNKNOWN. A FOLLOW UP MEDWATCH FORM 3500A WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    THE USER FELL BACKWARD AND THE ANTITIP BROKE. THE USER HIT THEIR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566939 TR WHEELCHAIR IOR TISPORT, LLC TR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other