BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIC SAFETY PEG KIT - PULL METHOD

    MDR report key: 8579426 · Received May 3, 2019

    Report

    Report Number
    3006646024-2019-00007
    Event Type
    Death
    Date Received
    May 3, 2019
    Report Date
    April 10, 2019
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10350770409792
    PMA / PMN Number
    K924065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 01 MAY 2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. AVANOS MEDICAL INC. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON "HAD DIFFICULTY REMOVING A 7180-20 PEG. THE PATIENT REFUSED AN ENDOSCOPY AT THAT TIME. [THE SURGEON] CUT THE TUBE AT SKIN LEVEL LEAVING THE BUMPER IN THE PATIENT¿S STOMACH. THE INTENTION WAS THAT HOPEFULLY THE BUMPER WOULD PASS. THE BUMPER CREATED AN OBSTRUCTION AND THE PATIENT DIED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372530 MIC SAFETY PEG KIT - PULL METHOD DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 7180-20 UNKNOWN 10350770409792

    Patients

    Seq Age Sex Outcome Treatment
    1 Death