BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F5 CORPUS VS

    MDR report key: 11181699 · Received January 15, 2021

    Report

    Report Number
    1221084-2021-00001
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 7, 2020
    Report Date
    January 15, 2021
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K143014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PERMOBIL REPRESENTATIVES EVALUATED THE DEVICE AND CONFIRMED, THROUGH FUNCTIONAL TESTING, THAT THE DEVICE MET SPECIFICATION AND WERE UNABLE TO IDENTIFY ANY MALFUNCTION HAVING OCCURRED WHICH MAY HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. EVALUATION OF THE DEVICE CONCLUDED NO PRODUCT MALFUNCTION OR DEVIATION IN OPERATION HAVING OCCURRED LEAVING PERMOBIL UNABLE TO ESTABLISH OR CONFIRM A POTENTIAL ROOT CAUSE FOR THIS REPORTED EVENT. IT SHOULD BE NOTED THE DEVICE WAS A DEMO BEING USED FOR THE PURPOSE OF EVALUATION AND WAS NOT PRESCRIBED FOR THIS SPECIFIC CLIENT. ALTHOUGH UNCONFIRMED, IT IS POSSIBLE THE ROOT CAUSE FOR THIS EVENT TO HAVE BEEN IMPROPER POSITIONING OF THE KNEE BLOCK SUPPORT. THE KNEE BLOCK SUPPORT BEING ADJUSTED TOO HIGH COULD APPLY EXCESSIVE PRESSURE TO THE END-USER'S PATELLA WHEN THEIR BODY WEIGHT WAS APPLIED DURING A STAND FUNCTION. THIS POTENTIAL WAS BROUGHT TO THE SERVICE PROVIDERS ATTENTION W/RECOMMENDATION THAT A THERAPIST BE PRESENT TO ENSURE PROPER POSITIONING IS ACHIEVED PRIOR TO STANDING EVALUATIONS. THE DHR WAS REVIEWED AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    PERMOBIL AB RECEIVED REPORT CLAIMING DURING AN EVALUATION OF THE STANDING SEATING FUNCTION OF THE DEVICE, THE END-USER CLAIMED HAVING RECEIVED A PAIN IN THEIR RIGHT KNEE, LATER THAT EVENING NOTED SOME BRUISING AND SWELLING. A PHYSICIAN DIAGNOSED THE INJURY AS CONSISTING OF SOFT TISSUE AND LIGAMENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72774 F5 CORPUS VS POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F5 CORPUS VS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1