BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOC PLUS ENDOTOUCH APPLIER 13" CVD

    MDR report key: 3909808 · Received February 26, 2014

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    Report

    Report Number
    1044475-2014-00034
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 5, 2014
    Manufacturer
    TELEFLEX
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE RECEIVED BY THE MFR, BUT INVESTIGATION IS STILL ON-GOING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE APPLIER DIDN'T LOAD THE CLIP PROPERLY, WHICH CAUSED IT TO FALL. IT IS UNK AT WHAT POINT THE CLIP FELL. NO REPORTED PT INJURY. PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119820 HOC PLUS ENDOTOUCH APPLIER 13" CVD ENDO APPLIER GDO TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1