BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO Z

    MDR report key: 11769875 · Received May 4, 2021

    Report

    Report Number
    3032618-2021-00005
    Event Type
    Injury
    Date Received
    May 4, 2021
    Report Date
    May 3, 2021
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT WAS RECEIVED ALLEGING THAT WHILE TRANSFERRING, A USER CUT THEIR THIGH ON THE CARBON FIBER FENDERED SIDEGUARD EQUIPPED WITH THEIR AERO Z MODEL CHAIR. THE REPORT CLAIMED THAT THE USER SOUGHT MEDICAL ATTENTION FOR THEIR INJURY. THE DHR FOR THE CHAIR WAS REVIEWED AND THE CHAIR PASSED APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS. IT MET SPECIFICATIONS WHEN IT LEFT THE FACILITY. THE SIDEGUARDS SUPPLIED WITH THE CHAIR WERE PURCHASED BY THE COMPANY AND INSTALLED AS IS ON THE CHAIR. THE PART IN QUESTION WAS NOT RETURNED FOR EVALUATION. A FOLLOW UP MEDWATCH FORM 3500A WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    THE USER ALLEGES THAT DURING TRANSFER HE CUT HIS THIGH ON THE SIDEGUARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669232 AERO Z MANUAL WHEELCHAIR IOR TISPORT, LLC AERO Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Other