BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL M5 CORPUS

    MDR report key: 22860687 · Received August 21, 2025

    Report

    Report Number
    1221084-2025-00012
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    May 15, 2025
    Report Date
    August 21, 2025
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    UDI-DI
    17330818334562
    PMA / PMN Number
    K123290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL RECEIVED CORRESPONDENCE FROM LEGAL COUNSEL REPRESENTING THE END-USER WHERE IS WAS CLAIMED THE DEVICE ELEVATED WITHOUT THE END-USER PHYSICALLY ENGAGING A SEAT COMMAND. THIS ACTION REPORTEDLY CAUSED THE END-USER TO LOSE POSITIONING AND FALL TO THE GROUND, WHERE THE ENSUING FALL REPORTEDLY RESULTED IN AN UNDEFINED SERIOUS INJURY TO THE END-USER'S ANKLE AND KNEE. REVIEW OF THE DEVICE HISTORY SHOWN THE DEVICE HAVING SHIPPED WITH -20° ANTERIOR TILT FEATURE, AND AFTER HEARING OF THE INCIDENT FROM THE PROVIDER, A PERMOBIL REPRESENTATIVE REMOVED THE ANTERIOR TILT FEATURE FROM THE DEVICE PROGRAMMING. THE DEVICE HAS BEEN INSPECTED BY PERMOBIL TO WHICH THEY NOTICED THE FRONT LIFT ACTUATOR NOT HOLDING SECURE AFTER COMING OUT OF A TILT POSITION. THIS ACTION WOULD ALLOW THE SEATING TO TILT SLIGHTLY FORWARD WHEN NOT HOLDING. INTERVIEWS WITH THE END-USER DID NOT MAKE ANY CLAIMS THIS FOUND ACTUATOR MOVEMENT WAS WHAT OCCURRED TO HAVE CONTRIBUTED TO THE EVENT, BUT PERMOBIL NOTED THE IRREGULARITY AND GENERATED PARTS QUOTE TO ADDRESS. ALTHOUGH AN INSPECTION INDICATED A COMPONENT FAILURE BEING ACTIVE, PERMOBIL IS UNABLE TO REACH A DETERMINATION AT THIS TIME AS TO THE ACTUAL CAUSE FOR THE EVENT WITHOUT SPECULATION. IF ANY NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    PERMOBIL RECEIVED REPORT FROM LEGAL REPRESENTATIVE FOR THE END-USER CLAIMING THE END-USER HAVING SUSTAINED INJURIES RELATED TO AN ALLEGED MALFUNCTION WITH THEIR M5 CORPUS PWC. REPORT CLAIMS THE CHAIR RAISED UNEXPECTEDLY WHICH CAUSED THE END-USER TO FALL TO THE FLOOR WHERE THEY REPORTEDLY SUFFERED UNDESCRIBED SERIOUS INJURIES TO THEIR LEFT ANKLE AND KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203848 PERMOBIL M5 CORPUS POWERED WHEELCHAIR ITI PERMOBIL INC. M5 CORPUS N/A 17330818334562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other