BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC SAFETY PEG KIT - PULL METHOD

    MDR report key: 15167655 · Received August 4, 2022

    Report

    Report Number
    3006646024-2022-00020
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 13, 2022
    Report Date
    August 4, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770445991
    PMA / PMN Number
    K924065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    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 02 AUG 2022 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL INC..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 AVANOS MEDICAL COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP-GHC-22-02522.THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3006646024-2022-00021 FOR THE SECOND REPORT. REFER TO 3006646024-2022-00022 FOR THE THIRD REPORT. IT WAS REPORTED, THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) INTERNAL BUMPER CAME LOOSE FROM THE TUBE AND HAD TO BE REMOVED IN THE GASTROINTESTINAL (GI) LAB; THE PEG WAS LEFT IN [THE PATIENT¿S] STOMACH OVER 3 MONTHS. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787058 MIC SAFETY PEG KIT - PULL METHOD DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 8180-20 UNKNOWN 00350770445991

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown