BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HT APPLIER MED 8" CVD

    MDR report key: 2901475 · Received January 3, 2013

    Report

    Report Number
    1044475-2013-00006
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 23, 2012
    Report Date
    December 12, 2012
    Manufacturer
    TELEFLEX
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR MFR TO EVALUATE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: "THE USER FOUND THAT THE APPLIER CANNOT HOLD THE CLIP TIGHTLY AND THE CLIP DROPPED BEFORE DEPLOYMENT". NO PT INJURY REPORTED. REQUESTED ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3037 WECK HT APPLIER MED 8" CVD CLIP APPLIER FZP TELEFLEX 06M1039047

    Patients

    Seq Age Sex Outcome Treatment
    1