BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK L CLIPS 6/CART 84/BOX

    MDR report key: 4412065 · Received January 8, 2015

    Report

    Report Number
    3003898360-2015-00004
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    December 8, 2014
    Report Date
    December 9, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    MCH
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD (DHR) INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. NO CORRECTIVE ACTION CAN BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE DEFECT. AT THIS TIME DUE TO THE LACK OF DEFECTIVE PRODUCT IT IS NOT POSSIBLE TO CONFIRM THE COMPLAINT AND TO DETERMINE THE ROOT CAUSE. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLIPS DIDN'T CLOSE DURING A LRC+LPND+BRICKER PROCEDURE. NO PT INJURY REPORTED. PT CURRENT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17418 HEMOLOK L CLIPS 6/CART 84/BOX MCH TELEFLEX MEDICAL 73E1400545

    Patients

    Seq Age Sex Outcome Treatment
    1