BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS

    MDR report key: 21047949 · Received December 31, 2024

    Report

    Report Number
    1221084-2024-00027
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    October 1, 2024
    Report Date
    December 31, 2024
    Manufacturer
    PERMOBIL AB
    Product Code
    ITI
    PMA / PMN Number
    K143014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL AB RECEIVED REPORT CLAIMING THE END-USER HAVING INADVERTENTLY DRIVEN THE POWER WHEELCHAIR INTO A WALL DUE TO NUMBNESS IN THEIR HAND. THE IMPACT RESULTED IN THE END-USER SUSTAINING 3 BROKEN TOES AS THEIR FOOT WAS HANGING OVER THE EDGE OF THE FOOTPLATE AND WAS UNABLE TO SLIDE BACKWARDS DUE TO THE HEEL CUP DESIGN OF THE FOOTPLATE. ALL ACCOUNTS PROVIDED CLAIM INADVERTENT USE ERROR AS BEING THE CAUSE FOR THE EVENT, WITH NO CLAIM OR ALLEGATION BEING MADE OF ANY PRODUCT MALFUNCTION HAVING OCCURRED. DEVICE IS REPORTED TO REMAIN FULLY OPERATIONAL WITH NO NOTABLE ISSUES. A REQUEST HAS BEEN MADE TO PERMOBIL AB FOR A CUSTOM MODIFICATION TO EXTEND THE LENGTH OF THE FOOTPLATE TO WHERE IT ENCOMPASSES THE ENTIRE LENGTH OF THE END-USER FOOT IN EFFORTS TO AVOID ANY CHANCE FOR RECURRENCE. 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 A REPORT CLAIMING DURING NORMAL USE OF THE DEVICE, THE END-USER WAS UNABLE TO CONTROL THE ELECTRIC WHEELCHAIR AS USUAL DUE TO THE COLD AND NUMBNESS IN THEIR FINGERS WHICH CAUSED THEM TO HIT A WALL. THE LEFT FOOT GOT CAUGHT ON THE FOOTPLATE, AND BECAUSE OF ITS BOWL SHAPE, THEIR FOOT WAS UNABLE TO MOVE BACKWARDS AND BECAME TRAPPED. THE IMPACT REPORTEDLY LED TO AN INJURY REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206890 PERMOBIL F5 CORPUS POWERED WHEELCHAIR ITI PERMOBIL AB F5 CORPUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization