BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - OTW

    MDR report key: 10537847 · Received September 15, 2020

    Report

    Report Number
    9611594-2020-00184
    Event Type
    Injury
    Date Received
    September 15, 2020
    Date of Event
    August 24, 2020
    Report Date
    December 4, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    PMA / PMN Number
    K924065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2, A3, A4, B5. CORRECTED DATA: D10 ALL INFORMATION REASONABLY KNOWN AS OF 05 OCT 2020 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-JHC-20-00336. 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. PHOTOS OF THE DEVICE WERE PROVIDED BY THE CUSTOMER AND CONFIRMED THE REPORTED EVENT; HOWEVER, ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 03 DEC 2020 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 15-SEP-2020 INDICATED THE INCIDENT OCCURRED (B)(6) 2020 AND ON (B)(6) 2020 THE "PATIENT'S RESPIRATORY CONDITION TURNED FOR THE WORSE IN THE EVENING. SYSTEMIC INFLAMMATORY REACTION INCREASED. ANTIBIOTIC MEDICATION TREATMENT WAS STARTED. [THE PATIENT'S] SCHEDULE FOR LEAVING THE HOSPITAL WAS POSTPONED. (B)(6) 2020 ANTIBIOTIC MEDICATION TREATMENT WAS ONGOING. SPO2 92-95%. IT IS SUSPECTED THAT THE PATIENT'S RESPIRATORY CONDITION TURNED FOR THE WORSE BECAUSE OF HER BASAL DISEASE." NO INFORMATION WAS AVAILABLE REGARDING MEDICAL TREATMENT FOR THE ESOPHAGEAL DAMAGE. THE ACTUAL SAMPLE WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. PHOTOS OF THE DEVICE WERE PROVIDED BY THE CUSTOMER. ALL INFORMATION REASONABLY KNOWN AS OF 14 SEP 2020 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. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEG TUBE WAS REPLACED ON (B)(6) 2020. WHEN FASTENING THE TUBE WITH SNARE WHILE REMOVING IT WITH AN ENDOSCOPE, THE TUBE WAS TORN OFF. BECAUSE OF THAT, THE PATIENT'S ESOPHAGUS WAS DAMAGED WHILE REMOVING THE TUBE AND THE PATIENT HAD TO BE HOSPITALIZED. IT WAS NOTED THAT THE DEVICE WAS CUT INCORRECTLY WHILE REMOVING THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000812 MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - OTW DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 0630-20J UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization