BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TILITE AERO T

    MDR report key: 16593169 · Received March 22, 2023

    Report

    Report Number
    3032618-2023-00003
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    October 22, 2022
    Report Date
    March 22, 2023
    Manufacturer
    PERMOBIL
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL WAS FIRST INFORMED OF THIS POSSIBLE ADVERSE EVENT ON (B)(6) 2023. PERMOBIL HAS NOT RECEIVED ANY INFORMATION ABOUT THE REPORTED EVENT OTHER THAN THE DATE AND THE TYPE OF ALLEGED INJURY. PERMOBIL HAS NOT RECEIVED ANY REPORTS, CLAIMS, OR ALLEGATIONS OF A PRODUCT MALFUNCTION HAVING OCCURRED THAT WOULD HAVE CONTRIBUTED TO THIS REPORTED EVENT. THE DHR HAS BEEN REVIEWED AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION ON APRIL 24, 2018. 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

    ON (B)(6) 2023, NUMOTION NOTIFIED PERMOBIL OF A POSSIBLE ADVERSE EVENT THAT MAY HAVE INVOLVED A TILITE MANUAL WHEELCHAIR. NUMOTION INFORMED PERMOBIL THAT IT RECEIVED A CALL FROM THE USER'S ATTORNEY ALLEGING A FRACTURED TIBIA THAT OCCURRED ON (B)(6) 2022. OTHER THAN THE ALLEGED INJURY, NO FURTHER DETAILS WERE PROVIDED. BASED ON THE LIMITED INFORMATION PROVIDED TO PERMOBIL, THE PRODUCT IN QUESTION IS BELIEVED TO BE A TI-SPORT FRAME MANUFACTURED ON APRIL 24, 2018 WITH THE SERIAL NUMBER (B)(4). PERMOBIL HAS NO INFORMATION ABOUT HOW THE ALLEGED INJURY OCCURRED AND HAVE NOT RECEIVED ANY INFORMATION INDICATING AN ALLEGED PRODUCT DEFICIENCY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450739 TILITE AERO T MANUAL WHEELCHAIR IOR PERMOBIL AERO T N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization