BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TILITE ZR

    MDR report key: 18668428 · Received February 8, 2024

    Report

    Report Number
    3032618-2024-00001
    Event Type
    Injury
    Date Received
    February 8, 2024
    Report Date
    April 8, 2025
    Manufacturer
    PERMOBIL
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL WAS FIRST INFORMED OF THIS ADVERSE EVENT ON JANUARY 9TH, 2024. PERMOBIL HAS RECEIVED LIMITED INFORMATION ABOUT THE REPORTED EVENT. PERMOBIL IS NOT AWARE OF A PRODUCT MALFUNCTION HAVING OCCURRED THAT WOULD HAVE CONTRIBUTED TO THIS REPORTED EVENT. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO DISTRIBUTION ON OCTOBER 26 2020. PERMOBIL HAS RECEIVED MINIMAL INFORMATION ABOUT THE CIRCUMSTANCES OF THIS EVENT. IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE USER REPORTED TO THE DEALER THAT THE CENTER OF GRAVITY WAS TOO FAR BACK, CAUSING THE USER TO SUFFER A FALL IN (B)(6)2022 AND BREAK HIS WRIST. DETAILS OF THE FAILURE ARE UNKNOWN CURRENTLY. INFORMATION AND DETAILS OF THE INJURY ARE LIMITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225565 TILITE ZR MANUAL WHEELCHAIR IOR PERMOBIL ZR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention