BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACTION BOOTS, PAIR

    MDR report key: 8042568 · Received November 6, 2018

    Report

    Report Number
    8010652-2018-00027
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    September 10, 2018
    Report Date
    December 18, 2018
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT IN QUESTION WAS REQUESTED FOR INVESTIGATION BUT AT THE TIME OF THIS REPORT THE PRODUCT DIDN'T ARRIVE AT GETINGE-GMBH. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH, KEHLER STRASSE 31, RASTATT, GERMANY 76437. EXEMPTION # E2018004. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Description of Event or Problem · 0

    DURING THE PROCEDURE, A STRAP FROM THE PADDED LEATHER OF THE TRACTION BOOT WAS TORN. THE TRACTION BOOT WAS EXCHANGED FOR ANOTHER AND THE SURGERY WAS COMPLETED. WE HAVE CHOSEN TO REPORT DUE TO THE AMOUNT OF DELAY CAUSED DURING THE PROCEDURE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN QUESTION WAS REQUESTED FOR INVESTIGATION BUT AT THE TIME OF THIS REPORT THE PRODUCT DIDN'T ARRIVE AT GETINGE-(B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    THE AFFECTED MATERIAL WAS RETURNED TO THE MANUFACTURER AND INVESTIGATED. THE DAMAGE DESCRIBED BY THE CUSTOMER COULD BE CONFIRMED. THE UPPER LEATHER BELT WAS TORN AT THE SECOND HOLE. AT THE TORN LEATHER BELT, SEVERAL SMALLER TEARS WERE FOUND. MOST OF THE ORIGINALLY CIRCULAR HOLES WERE DEFORMED TO SLOTTED HOLES. MOST OF THE DEFORMATION AND TEARS WERE FOUND IN THAT AREA OF THE LEATHER BELT THAT WAS TORN APART. WE ASSUME THAT SOME PRE-DAMAGE EXISTED AND HAS CONTRIBUTED TO THE FAILURE OF THIS LEATHER BELT. ANOTHER FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE FAILURE IS THAT THE PATIENTS FOOT MIGHT NOT HAVE BEEN SUITABLE FOR THE USED LEATHER BOOT. THE CUSTOMER STATED "DIFFICULTIES HAD TO BE FACED WHEN INSTALLING THE DEVICE: TOO MUCH TENSION WAS OBSERVED ON THE TRACTION BOOT." IN THE IFU (INSTRUCTIONS FOR USE) THE USER IS ADVISED TO CHECK ON THE PRODUCT PRIOR TO USE. ALSO THE USER IS WARNED TO ONLY USE A PRODUCT WHICH IS FULLY FUNCTIONAL AND IN GOOD WORKING ORDER. DUE TO THE GENERAL STATE OF THE PRODUCT (TEARS, SLOTTED HOLES) AND THE DIFFICULTIES FACED WHEN INSTALLING THE DEVICE, WE ASSUME THAT THE PRODUCT WAS PRE-DAMAGED IN THE COURSE OF USAGE (MANUFACTURED IN 2007) AND FINALLY TORN APART DURING THE DESCRIBED PROCEDURE. GETINGE- MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. (B)(4). EXEMPTION # E2018004. (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, A STRAP FROM THE PADDED LEATHER OF THE TRACTION BOOT WAS TORN. THE TRACTION BOOT WAS EXCHANGED FOR ANOTHER AND THE SURGERY WAS COMPLETED. WE HAVE CHOSEN TO REPORT DUE TO THE AMOUNT OF DELAY CAUSED DURING THE PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881094 TRACTION BOOTS, PAIR ACCESSORIES, OPERATING-ROOM, TABLE (KIT) FWZ HOLGER ULLRICH 10018800

    Patients

    Seq Age Sex Outcome Treatment
    0
    1