BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CLIP TRAY TAG FOR 45.716

    MDR report key: 3222545 · Received July 12, 2013

    Report

    Report Number
    1045834-2013-02737
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 18, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-TESTING IT WAS OBSERVED THAT THE "COLOR WAS FLAKING OFF" OF THE LABELS ON THE ANEURYSM TRAY DEVICE. ACCORDING TO THE REPORT, THE USER OBSERVED THAT THERE WAS "BUBBLING" UNDER THE PAINT. THE REPORTER INDICATED THAT THE "PINK COLOR" SEEMED TO BE AFFECTED THE MOST. THE ACTUAL DEVICE WAS USED IN THE SCHEDULED SURGERY AND SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, ADVERSE EVENTS, OR MEDICAL INTERVENTION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321559 L-CLIP TRAY TAG FOR 45.716 APPLIER, ANEURYSM CLIP HCI DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 ANEURYSM CLIP