BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT, ENFIT, 24 FR-PULL

    MDR report key: 20260451 · Received September 19, 2024

    Report

    Report Number
    3006646024-2024-00027
    Event Type
    Injury
    Date Received
    September 19, 2024
    Report Date
    January 10, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770445991
    PMA / PMN Number
    K924065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30264943, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 10-JAN-2025 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, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). 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.

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND UDI NUMBER ARE IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 19-SEP-2024 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, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP(B)(4). 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.

    Description of Event or Problem · 0

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 3006646024-2024-00026 FOR THE FIRST EVENT. REFER TO 3006646024-2024-00028 FOR THE THIRD EVENT. REFER TO 3006646024-2024-00029 FOR THE FOURTH EVENT. IT WAS REPORTED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH PLACEMENT OF PEG TUBE, THERE WAS AN ESOPHAGEAL SUPERFICIAL TEAR VISUALIZED AFTER PULLING THE PEG TUBE OVER THE GUIDEWIRE. NO ADDITIONAL INFORMATION WAS PROVIDED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430307 MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT, ENFIT, 24 FR-PULL DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 8180-20 30264943 00350770445991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other