BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TILITE ZR

    MDR report key: 17912909 · Received October 11, 2023

    Report

    Report Number
    3032618-2023-00004
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    September 8, 2023
    Report Date
    October 11, 2023
    Manufacturer
    PERMOBIL
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL WAS FIRST INFORMED OF THIS ADVERSE EVENT ON SEPTEMBER 12, 2023. 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 JUNE 13, 2023. 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 NEW USER REPORTED TO THE DEALER THAT THE UNI-LOCK BREAKS FAILED CAUSING THE USER TO FALL OUT OF THE CHAIR AND INJURE THE KNEE. DETAILS OF THE FAILURE ARE UNKNOWN CURRENTLY. INFORMATION AND DETAILS OF INJURY ARE LIMITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180900 TILITE ZR MANUAL WHEELCHAIR IOR PERMOBIL ZR N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other