BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS

    MDR report key: 13232473 · Received January 11, 2022

    Report

    Report Number
    1221084-2022-00001
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    November 12, 2021
    Report Date
    January 12, 2022
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K143014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION PROVIDED TO PERMOBIL AB FROM THE SERVICE PROVIDER CLAIM AS THE END-USER WAS OPERATING THEIR POWER WHEELCHAIR OUT-OF-DOORS ON A LOCAL STREET, THE DEVICE REPORTEDLY MANEUVERED INTO A CURB SIDE. IT WAS REPORTED UPON IMPACT, THE DEVICE ABRUPTLY STOPPED, FORCING THE END-USER TO LOSE POSITIONING AND FALL TO THE GROUND WHERE THEY WERE REPORTED TO HAVE SUSTAINED A BROKEN ANKLE. THE END-USER COULD NOT PROVIDE ANY INFORMATION AS TO WHAT MAY HAVE LED TO IMPACTING THE CURB, NOR WAS ANY CLAIM OR ALLEGATION MADE THAT THE PERMOBIL DEVICE MALFUNCTIONED OR DEVIATED IN OPERATION TO HAVE CONTRIBUTED TO THE EVENT. PERMOBIL TECHNICIANS INSPECTED THE DEVICE AND FOUND IT TO REMAIN FULLY OPERATIONAL WITH NO SIGNS OF ELECTRICAL OR MECHANICAL ISSUES THAT MAY HAVE CONTRIBUTED TO THIS EVENT. AS DEVICE WAS FULLY OPERATIONAL WITH NO SIGNS OF A PREVIOUS MALFUNCTION HAVING OCCURRED, IT IS PERMOBIL AB'S CONTENTION THAT THE MOST LIKELY CAUSE OF THE EVENT WAS USER ERROR IN MANEUVERING THE POWER WHEELCHAIR INTO A CURB SIDE THAT IS HIGHER THAN WHAT THE DEVICE WAS DESIGNED TO ACCOMMODATE. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED REPORT CLAIMING WHILE THE END-USER WAS DRIVING THEIR DEVICE OUT-OF-DOORS, THE DEVICE REPORTEDLY STRUCK A CURBSIDE WHICH CAUSED THE DEVICE TO STOP ABRUPTLY. THE SUDDEN STOPPAGE REPORTEDLY CAUSED THE END-USER TO LOSE POSITIONING AND FALL OUT OF THE SEATING TO THE GROUND WHERE IT WAS REPORTED THEY SUSTAINED SERIOUS INJURY REQUIRING MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050654 PERMOBIL F5 CORPUS POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F5 CORPUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization