BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL TI LITE MANUAL WHEELCHAIR

    MDR report key: 13499853 · Received February 8, 2022

    Report

    Report Number
    MW5107314
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    February 4, 2022
    Report Date
    February 4, 2022
    Manufacturer
    TI LITE (UNDER PERMOBIL) / TISPORT, LLC
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TI LITE MANUAL WHEELCHAIR MALFUNCTION ISSUES FOR TWO WHEELCHAIRS FOR THIS VETERAN (ZR SN (B)(4) AND (B)(4)). REAR WHEELS NOT STAYING ATTACHED TO CHAIR PROPERLY WITH FACTORY SETTINGS. EITHER AXLE SLEEVE AND/OR PIN LENGTH ISSUE AND ISSUE WITH RECEIVERS IN CAMBER TUBE LOOSENING UP. UNDERSIGNED CLINICIAN ALSO INFORMED THAT OTHER CO-WORKERS HAVE HAD SIMILAR ISSUES FOR TI LITE WHEELCHAIRS RECENTLY. I AM ENCOURAGING THEM TO SUBMIT SIMILAR REPORTS. ISSUES WERE NOTED WITH FACTORY SETTINGS OF CHAIR. CHANGES WERE NOT MADE TO THESE PARTS DURING FITTING BEFORE ISSUE WAS NOTICED. FDA SAFETY REPORT ID # (B)(4).

    Description of Event or Problem · 0

    TI LITE MANUAL WHEELCHAIR MALFUNCTION ISSUES FOR TWO WHEELCHAIRS FOR THIS VETERAN (ZR SN (B)(4) AND (B)(4)). REAR WHEELS NOT STAYING ATTACHED TO CHAIR PROPERLY WITH FACTORY SETTINGS. EITHER AXLE SLEEVE AND/OR PIN LENGTH ISSUE AND ISSUE WITH RECEIVERS IN CAMBER TUBE LOOSENING UP. UNDERSIGNED CLINICIAN ALSO INFORMED THAT OTHER CO-WORKERS HAVE HAD SIMILAR ISSUES FOR TI LITE WHEELCHAIRS RECENTLY. I AM ENCOURAGING THEM TO SUBMIT SIMILAR REPORTS. ISSUES WERE NOTED WITH FACTORY SETTINGS OF CHAIR. CHANGES WERE NOT MADE TO THESE PARTS DURING FITTING BEFORE ISSUE WAS NOTICED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757338 PERMOBIL TI LITE MANUAL WHEELCHAIR WHEELCHAIR, MECHANICAL IOR TI LITE (UNDER PERMOBIL) / TISPORT, LLC ZR
    757339 PERMOBIL TI LITE MANUAL WHEELCHAIR WHEELCHAIR, MECHANICAL IOR TI LITE (UNDER PERMOBIL) / TISPORT, LLC ZR

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention