BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY* G-14 INTRODUCER KIT

    MDR report key: 6051946 · Received October 24, 2016

    Report

    Report Number
    9611594-2016-00141
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Report Date
    October 5, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    KGC
    PMA / PMN Number
    PK080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR (B)(4) WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANCHOR FROM THE GASTROPEXY KIT FAILED AFTER TWO AND A HALF WEEKS. THE ANCHORS ALLEGEDLY MIGRATED THROUGH TO THE SKIN AT THREE WEEKS. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703084 MIC-KEY* G-14 INTRODUCER KIT ENTERAL FEED PERCUTANEOUS KGC HALYARD HEALTH 98431 AA6025R09

    Patients

    Seq Age Sex Outcome Treatment
    1