BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F5 CORPUS VS

    MDR report key: 12642934 · Received October 15, 2021

    Report

    Report Number
    1221084-2021-00035
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    September 16, 2021
    Report Date
    October 15, 2021
    Product Code
    IPL
    PMA / PMN Number
    K191874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL (B)(6) WAS CONTACTED BY AN OCCUPATIONAL THERAPIST FROM A REHAB FACILITY REPORTING DURING A GENERAL CARE EVALUATION FOR THEIR PATIENT, IT WAS DISCOVERED THEY HAD SUSTAINED A FRACTURE TO ONE OF THEIR TIBIA'S. INTERVIEWS CONDUCTED WITH THE END-USER CLAIM HAVING NO KNOWLEDGE OF WHEN THE INJURY OCCURRED OR HOW IT COULD HAVE OCCURRED. THE REHAB FACILITY REPORTED HAVING CONDUCTED AN INTERNAL INVESTIGATION, FINDING THE POWER WHEELCHAIR TO BE FULLY OPERATIONAL WITH NO ISSUES BEING FOUND. ALTHOUGH UNABLE TO CONFIRM, IT WAS THE OPERATIONAL THERAPIST'S THEORY THE END-USER SUSTAINED THE INJURY WHILE USING THE DEVICES STANDING FEATURE AS THE INJURY SUSTAINED WAS AT THE SAME LEVEL TO WHERE THE DEVICES KNEE BLOCK ASSEMBLY WAS POSITIONED FOR THE END-USER. THE OT MADE MENTION THAT THE KNEE BLOCK WAS POSITIONED CORRECTLY FOR THE END-USER BUT SPECULATED THE END-USER MAY NOT HAVE HAD THEIR FEET PROPERLY POSITIONED BEFORE INITIATING AN UN-SUPERVISED STANDING SEQUENCE. WITH THE INFORMATION PROVIDED, PERMOBIL IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE WITHOUT SPECULATION. PERMOBIL WILL CONTINUE TO MONITOR AND 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 AB RECEIVED REPORT CLAIMING WHILE PERFORMING GENERAL CARE, THE NURSING STAFF FOUND THE END-USER HAD SUSTAINED A FRACTURE OF THE TIBIA. IN THE FACILITY'S INTERNAL EVALUATION, IT WAS IDENTIFIED THAT OPERATION OF WHEELCHAIRS STANDING FEATURE AS A POSSIBLE CAUSE SINCE THE FRACTURE IS AT THE LEVEL OF THE KNEE SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537123 PERMOBIL F5 CORPUS VS POWERED WHEELCHAIR IPL F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization