BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK ENDO FASCIAL CLOSSURE SYSTEM

    MDR report key: 3868911 · Received April 28, 2014

    Report

    Report Number
    1044475-2014-00113
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    February 5, 2014
    Report Date
    April 7, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DETAILS OR PRODUCT HAVE BEEN PROVIDED. IT IS NOT POSSIBLE TO PERFORM A DEVICE HISTORY RECORD (DHR) REVIEW OR PRODUCT REVIEW WITH THE DETAILS THAT ARE KNOWN TO DATE. THEREFORE, NO FURTHER ACTION CAN BE TAKEN.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED VIA MONTHLY MAUDE REPORT REVIEW FOR (B)(4) 2014: NO DETAILS PROVIDED EXCEPT THAT THE PHYSICIAN USED AN EFX SYSTEM "WHICH RESULTED IN A PERFORATED BOWEL." PT CURRENT CONDITION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254105 WECK ENDO FASCIAL CLOSSURE SYSTEM FASCIAL CLOSSURE SYSTEM GCJ TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1