BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXOR II

    MDR report key: 11197267 · Received January 19, 2021

    Report

    Report Number
    3011386779-2021-00043
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    December 16, 2020
    Report Date
    July 14, 2021
    Manufacturer
    INTEGRUM AB
    Product Code
    PJY
    UDI-DI
    07340152100634
    PMA / PMN Number
    P190009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    INTEGRUM AB RECEIVED AN E-MAIL FROM VP FOR PROSTHETICS FROM INTEGRUM INC THAT A PATIENT REPORTS THE AXOR FALLING OF A MINIMUM OF 10 TIMES IN THE PAST WEEK. A LOAN UNIT HAS BEEN SENT TO THE PATIENT IN USA IMMEDIATELY. IT IS STILL NOT CLEAR WHAT SERIAL NUMBER THE UNIT HAS OR IF IT HAS BEEN SENT BACK TO INTEGRUM AB. IT IS ALSO UNCLEAR WHICH HEALTH PROFESSIONAL HAS REPORTED THE INCIDENT INITIALLY TO INTEGRUM INC. AN E-MAIL SENT TO VP IN INTEGRUM INC TO CLARIFY AND TO FOLLOW UP ON MORE INFORMATION REGARDING THE UNIT (18TH OF JANUARY). 07/14/2021: INTEGRUM AB HAS BEEN INFORMED BY REPRESENTATIVE FROM INTEGRUM INC, WHO HAS BEEN IN CONTACT WITH THE RESPONSIBLE PROSTHETIST, THAT THE DEVICE WILL NOT BE RETURNED TO INTEGRUM FOR TECHNICAL INVESTIGATION. WHEN CHECKING THE DEVICE, THE "PROSTHETIST" FOUND THAT THE UNIT WAS VERY DIRTY AND NEEDED TO BE CLEANED. ONCE A THOROUGH CLEANING WAS PERFORMED HE FELT IT DID NOT NEED TO BE RETURNED. THE CASE WILL THEREFORE BE CLOSED.

    Description of Event or Problem · 1

    INTEGRUM (B)(4) RECEIVED AN E-MAIL FROM VP FOR PROSTHETICS FROM INTEGRUM INC THAT A PATIENT REPORTS THE AXOR FALLING OF A MINIMUM OF 10 TIMES IN THE PAST WEEK. A LOAN UNIT HAS BEEN SENT TO THE PATIENT IN USA IMMEDIATELY. IT IS STILL NOT CLEAR WHAT SERIAL NUMBER THE UNIT HAS OR IF IT HAS BEEN SENT BACK TO INTEGRUM (B)(4). IT IS ALSO UNCLEAR WHICH HEALTH PROFESSIONAL HAS REPORTED THE INCIDENT INITIALLY TO INTEGRUM INC. AN E-MAIL SENT TO VP IN INTEGRUM INC TO CLARIFY AND TO FOLLOW UP ON MORE INFORMATION REGARDING THE UNIT (18TH OF JANUARY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95515 AXOR II AXOR II PJY INTEGRUM AB 1288 07340152100634

    Patients

    Seq Age Sex Outcome Treatment
    1 Other