BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHOX

    MDR report key: 7113695 · Received December 13, 2017

    Report

    Report Number
    1314417-2017-00004
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Report Date
    November 27, 2017
    Manufacturer
    ETHOX LLC.
    Product Code
    KDH
    PMA / PMN Number
    K962850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT RETURNED BY THE CUSTOMER, BUT THEY DID PROVIDE A LOT NUMBER AND A PHOTO OF THE DEVICE AFTER USAGE. AN INVENTORY EVALUATION WAS PERFORMED ON CURRENT PRODUCT IN INVENTORY. THE Q.E. VISUALLY INSPECTED 8 DEVICES. THE INSPECTED DEVICES DID NOT SHOW ANY ABNORMALITIES. THE INVESTIGATOR'S CONCLUSION IS THAT THE AFFECTED DEVICE COULD NOT HAVE POSSIBLY BEEN PRODUCED OR SHIPPED IN THE CONDITION DEPICTED IN PHOTO SUPPLIED BY CUSTOMER. IN ADDITION, THE PRACTITIONER COULD NOT HAVE POSSIBLY INSERTED THE DEVICE IN THIS CONDITION. THE DEVICE COULD ONLY HAVE BECOME KNOTTED IN THE PATIENT'S STOMACH. RE-CREATION OF THE INCIDENT COULD NOT BE PERFORMED DUE TO MANY VARIABLES. THE INVESTIGATOR'S CONCLUSION IS THAT THE TUBE WAS OVER-INSERTED INTO THE PATIENT CAUSING IT TO FORM A KNOT. THE AFFECTED DEVICE WAS SHIPPED WITH AN IFU INSTRUCTING THE USER TO INSERT THE TUBE PER THE APPROVED STANDARD HOSPITAL PROCEDURE. THE INVESTIGATOR'S CONCLUSION IS THAT THE INCIDENT IN QUESTION WAS THE RESULT OF IMPROPER USAGE OF THE DEVICE. THERE IS NO INDICATION THAT THE PRODUCT WAS DEFECTIVE. THERE IS NO RECORD OF ANY PREVIOUS INCIDENTS LIKE THE ONE IN QUESTION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT "THE LAVAGE TUBING WAS IN A KNOT WHEN PULLED FROM THE PATIENT." NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893912 ETHOX GASTRIC LAVAGE KDH ETHOX LLC. 950095903 308337

    Patients

    Seq Age Sex Outcome Treatment
    1