BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRA

    MDR report key: 11780482 · Received May 5, 2021

    Report

    Report Number
    3032618-2021-00006
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    February 5, 2021
    Report Date
    May 5, 2021
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A NOTIFICATION OF THE ADVERSE EVENT WAS RECEIVED THROUGH A LETTER FROM A LAW FIRM. THE FULL EXTENT OF THE INJURIES ARE UNKNOWN. PICTURES OF THE BACK SUPPORT WERE RECEIVED SHOWING THAT A BOLT BROKE, BUT THE BACK SUPPORT HAS NOT BEEN RETURNED FOR EVALUATION. THE BACK SUPPORT IS A SUPPLIED PART THAT WAS INSTALLED ON THE CHAIR. NO DETERMINATION OF THE ALLEGED FAILURE CAN BE MADE. THE DHR FOR THE CHAIR WAS REVIEWED AND THE CHAIR PASSED ALL APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS. IT MET ALL SPECIFICATIONS WHEN IT LEFT THE FACILITY. FURTHER REQUESTS FOR INFORMATION HAVE BEEN SUBMITTED TO THE LAW FIRM AND IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    USER ALLEGES THAT DURING NORMAL USE THE BACK REST SNAPPED BACKWARDS CAUSING THE USER TO TIP OVER BACKWARDS AND KNEE HIMSELF IN THE FACE, BREAKING HIS NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677510 TRA MANUAL WHEELCHAIR IOR TISPORT, LLC TRA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other