BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WECK HEM-O-LOK 5MM ENDO MANUAL APPLIER

    MDR report key: 743035 · Received June 9, 2006

    Report

    Report Number
    1044475-2006-00014
    Event Type
    Injury
    Date Received
    June 9, 2006
    Report Date
    June 9, 2006
    Manufacturer
    WECK, TELEFLEX MEDICAL
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TELEFLEX MECICAL IS CURRENTLY IN THE PROCESS OF RETRIEVING THE DEVICE FOR EVALUATION FROM THE USER FACILITY. IF THE DEVICE IS OBTAINED, TELEFLEX MEDICAL WILL PROVIDE A FOLLOW UP REPORT WITH THE EVALUATION SUMMARY OF THE APPLIER.

    Description of Event or Problem · 1

    IT WAS REQUESTED TO TELEFLEX MEDICAL THAT DURING A LAPROSCOPIC SPLENECTOMY, VESSELS WERE "SLASHED AND TORN CAUSING HEMORRHAGING" SURGEON WAS REQUIRED TO PERFORM A SPLENECTOMY. PATIENT IS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOK 5MM ENDO MANUAL APPLIER POLYMER LIGATION CLIP APPLIER GDO WECK, TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention