BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMOBIL F5

    MDR report key: 9673483 · Received February 5, 2020

    Report

    Report Number
    1221084-2020-00004
    Event Type
    Death
    Date Received
    February 5, 2020
    Date of Event
    January 14, 2020
    Report Date
    February 5, 2020
    Manufacturer
    PERMOBIL INC.
    Product Code
    ITI
    UDI-DI
    17330818229844
    PMA / PMN Number
    K143180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS PROVIDED BY THE END-USERS FAMILY MEMBER CLAIM AS THE END-USER WAS UTILIZING THE DEVICE WHILE IN THEIR GARAGE, THEY WERE ATTEMPTING TO LIGHT A WOOD BURNING STOVE USING A PROPANE TORCH NORMALLY USED FOR WEED CONTROL. REPORTS INDICATE THE END-USER HAD LOST THEIR GRIP OF THE TORCH HANDLE, DROPPING IT IN THEIR LAP WHICH SUBSEQUENTLY IGNITED THE END-USERS CLOTHING. REPORTS INDICATE THE END-USER WAS TRANSPORTED TO THE AREA BURN CENTER WHERE THEY EVENTUALLY SUCCUMBED AND DIED AFTER SUFFERING 3RD DEGREE BURNS TO OVER 85% OF THEIR BODY. ALL ACCOUNTS RECEIVED CLAIM THIS UNFORTUNATE INCIDENT WAS STRICTLY USE ERROR AND THE DEVICE DID NOT DEVIATE OR MALFUNCTION IN ANY WAY TO HAVE CONTRIBUTED TO THIS EVENT. AS THE RESULT OF THE EXTERNAL THERMAL ACTIVITY, THE DEVICE SUSTAINED CONSIDERABLE DAMAGES RENDERING IT INOPERABLE. THE DHR WAS REVIEWED AND DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    RECEIVED REPORT CLAIMING AS THE END-USER WAS ATTEMPTING TO LIGHT A WOOD BURNING STOVE WITH A TORCH, THEY INADVERTENTLY DROPPED THE TORCH IN THEIR LAP SUBSEQUENTLY IGNITING THEIR CLOTHING. END-USER WAS REPORTED TO HAVE SUSTAINED GRAVE INJURIES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132733 PERMOBIL F5 POWERED WHEELCHAIR ITI PERMOBIL INC. F5 N/A 17330818229844

    Patients

    Seq Age Sex Outcome Treatment
    1 Death