BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M3 CORPUS

    MDR report key: 10063050 · Received May 15, 2020

    Report

    Report Number
    1221084-2020-00025
    Event Type
    Injury
    Date Received
    May 15, 2020
    Date of Event
    April 12, 2020
    Report Date
    May 15, 2020
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS PROVIDED CLAIM AS THE END-USER WAS TRANSITIONING FROM A PAVED BIKEWAY PATH ON TO A MORE ROUGH TERRAIN ALONG SIDE THE PATH, THE END-USER REPORTEDLY LOST CONTROL OF THE DEVICE ALLOWING IT, WITH END-USER, TO VEER INTO A DITCH. REPORTS STATE THE DEVICE WAS UNABLE TO REMAIN IN THE UPRIGHT POSITION AND LANDED ON TOP OF THE END-USER RESULTING IN SEVERAL BROKEN BONES REQUIRING MEDICAL INTERVENTION. THE END-USER DID NOT MAKE ANY CLAIMS OR ALLEGATIONS OF A DEVICE MALFUNCTION HAVING OCCURRED STATING HAVING A VAGUE RECOLLECTION OF THE EVENT. THE DEVICE WAS RETURNED TO PERMOBIL AB FOR EVALUATION TO WHICH DAMAGES TO THE SEATING ELECTRONICS WERE DISCOVERED WHICH RENDERED THE DEVICE UNABLE TO DRIVE. THE DAMAGES WERE DETERMINED TO HAVE BEEN CAUSED AS THE END RESULT OF THE DEVICE FALLING OVER. UPON REPLACING AFFECTED COMPONENTS, THE DEVICE RETURNED TO FULL OPERATION WITH NO FURTHER OPERATIONAL ISSUES NOTED. PERMOBIL COULD NOT CONFIRM A PRODUCT MALFUNCTION HAVING OCCURRED WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. DEVICE WAS RETURNED TO LOCAL PROVIDER TO BE DELIVERED BACK TO THE END-USER THE DHR WAS REVIEWED AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING AS THE END-USER WAS DRIVING THE DEVICE ALONG A PAVED PATHWAY; UPON EXITING THE PATHWAY ON TO A HARD SHOULDER, THE END-USER LOST CONTROL OF THE DEVICE CAUSING IT, AND THE END-USER, TO FALL INTO A DITCH. REPORT INDICATES THE DEVICE LANDED ON TOP OF THE END-USER RESULTING IN SERIOUS INJURIES REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525489 PERMOBIL M3 CORPUS POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) M3 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization