BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL F3 CORPUS

    MDR report key: 17693012 · Received September 6, 2023

    Report

    Report Number
    1221084-2023-00018
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    January 29, 2021
    Report Date
    September 6, 2023
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    UDI-DI
    17330818676433
    PMA / PMN Number
    K143180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL COUNSEL RECEIVED A LETTER OF CIVIL COMPLAINT AGAINST PERMOBIL CLAIMING NEGLIGENCE IN FAILURE TO PROVIDE PRODUCT WITH PROPER POSITIONING NEEDS FOR THE END-USER WHICH REPORTEDLY LED TO THE END-USER DEVELOPING A STAGE 4 PRESSURE ULCER ON THEIR LEFT FOOT REQUIRING MULTIPLE SURGERIES TO ADDRESS, EVENTUALLY LEADING TO THE AMPUTATION OF THE LEFT FOOT. IN THE CLAIM IT IS ALLEGED THAT PERMOBIL FAILED TO BUILD THE DEVICE ACCORDING TO SPECIFICATION IN THAT AN 18" WIDE BACKREST WAS ORDERED, BUT PERMOBIL PROVIDED A 16" WIDE. REVIEW OF DEVICE HISTORY RECORDS INDICATES A 16" WIDE BACK WAS ORIGINALLY QUOTED BY DEALER, ORDERED, AND DEVICE SHIPPED WITH A 16"W BACK. THE PETITION ALSO CLAIMS A BENT FOOTPLATE AS ALSO BEING A CONTRIBUTING FACTOR WITH THE REPORTED INJURY, AND THAT SERVICE PARTS WERE REQUIRED TO CORRECT. REVIEW OF DEVICE HISTORY RECORDS DOES NOT HAVE ANY SUPPORTING EVIDENCE OF PERMOBIL BEING CONTACTED TO REPLACE OR REPAIR ANY COMPONENTS RELATED TO AN ALLEGED MALFUNCTION AS DESCRIBED. THE PRIMARY ALLEGATION IS THE FAILURE TO MEET THE END-USER'S SPECIFIC PHYSICAL REQUIREMENTS AND PROVIDE ADEQUATE SUPPORT TO MEET THEIR PHYSICAL NEEDS. PERMOBIL RECORDS INDICATE THE DEVICE HAVING BEEN BUILT TO SPECIFICATION, AND THAT NO PRODUCT MALFUNCTION HAVING OCCURRED TO WHICH THIS REPORTED EVENT CAN BE ATTRIBUTED. PERMOBIL IS UNABLE TO REACH A DETERMINATION AS TO POSSIBLE ROOT CAUSE OF THE EVENT WITHOUT SPECULATION. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    RECEIVED CLAIM THAT DUE TO IMPROPER POSITIONING OF POWER WHEELCHAIR SEATING, RESULTED IN A PRESSURE ULCER ON LEFT FOOT REQUIRING MULTIPLE SURGERIES TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224939 PERMOBIL F3 CORPUS POWERED WHEELCHAIR ITI PERMOBIL INC. F3 CORPUS N/A 17330818676433

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization