BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEM-O-LOK CLIPS, MEDIUM-LARGE

    MDR report key: 2060848 · Received March 11, 2011

    Report

    Report Number
    3003898360-2011-00085
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 17, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR FOR EVALUATION, THEREFORE, THE INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: BREAKAGE OF A CLIP INTO TWO PIECES OCCURRED DURING APPLICATION OF THE CLIP TO THE VESSEL. THE BROKEN PIECES WERE RETRIEVED FROM THE PT'S BODY. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOK CLIPS, MEDIUM-LARGE HEM-O-LOK CLIPS FZP TELEFLEX MEDICAL NA 01K0800187

    Patients

    Seq Age Sex Outcome Treatment
    1