BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK ENDO FASCIAL CLOSURE SYSTEM

    MDR report key: 4349744 · Received December 12, 2014

    Report

    Report Number
    1044475-2014-00347
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    November 11, 2014
    Report Date
    November 12, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE AT THE TIME OF THIS REPORT. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: DURING SURGERY, THE TIP OF THE EFX BROKE OFF INTO THE PT. THE NEEDLE WAS BEING INSERTED, IT MISSED THE SILICONE AND HIT THE PLASTIC SURROUNDING THE SILICONE. THE TIP BROKE OFF WHERE THE HOOK IS LOCATED. THE SURGEON WAS ABLE TO RETRIEVE THE TIP AND REMOVED IT FROM THE PT. THE PT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808129 WECK ENDO FASCIAL CLOSURE SYSTEM GCJ TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1