BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS VS

    MDR report key: 23914941 · Received December 29, 2025

    Report

    Report Number
    1221084-2025-00018
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    October 7, 2025
    Report Date
    December 29, 2025
    Manufacturer
    PERMOBIL AB
    Product Code
    IPL
    PMA / PMN Number
    K191874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO PERMOBIL FRANCE THAT THE CHEST BAR OF THE WHEELCHAIR DETACHED DURING A TRIAL WITH A USER STANDING. INFORMATION RECEIVED BY ANSM INFORMED PERMOBIL THAT THE USER WAS INJURED DURING THIS, DUE TO TIPPING FORWARD, WHERE THE USER FRACTURED BOTH OF THEIR TIBIAS. THE DEALER REPORTED THAT THE CHEST BAR DETACHED BECAUSE ONE OF THE TWO BRACKETS THAT HOLD THE CHEST SUPPORT BECAME DETACHED FROM THE ARMREST. THE BRACKET REPORTEDLY DETACHED BECAUSE BOTH BOLTS THAT HOLD IT TO THE ARMRESTS UNTHREAD AND FELL OUT. THE WHEELCHAIR FROM THIS INCIDENT HAS BEEN IN USED AS DEMO CHAIR FOR OVER TWO YEARS. THE DEALER STATED THAT THEY ADJUSTED THE WHEELCHAIR BEFORE THE TRIAL, AND THE ADJUSTMENTS INCLUDED THE BRACKET THAT HOLDS THE CHEST BAR THE DEALER ALSO STATED THAT THE SCREWS THAT FASTEN THE DETACHED BRACKET TO THE ARMREST WERE OF TWO DIFFERENT LENGTH BUT THAT THEY WOULD FASTEN. WITH THE INFORMATION PROVIDED, PERMOBIL'S DETERMINATION IS IMPROPER/LACK OF MAINTENANCE AS BEING THE CAUSE FOR THE REPORTED INCIDENT. REVIEW OF THE DHR INDICATED THE DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED A REPORT CLAIMING WHILE THE END-USER WAS USING THE STAND FEATURE, THE CHEST SUPPORT WAS REPORTED TO HAVE BECOME DETACHED. THIS ALLOWED THE END-USER TO LOSE UPRIGHT POSITIONING AND FALL FORWARD, RESULTING IN AN INJURY REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084123 PERMOBIL F5 CORPUS VS POWERED WHEELCHAIR IPL PERMOBIL AB F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization