BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 13711887 · Received March 9, 2022

    Report

    Report Number
    3006646024-2022-00009
    Event Type
    Injury
    Date Received
    March 9, 2022
    Date of Event
    January 10, 2022
    Report Date
    March 9, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770409832
    PMA / PMN Number
    K924065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 08 MAR 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 (B)(4).

    Description of Event or Problem · 0

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2022-00010 FOR THE SECOND REPORT . IT WAS REPORTED THAT THERE WAS AN INCIDENT INVOLVING THE SAFETY SCALPEL IN THE PEG KIT; A USER CUT THEMSELVES WHEN OPENING THE SCALPEL. ADDITIONAL INFORMATION RECEIVED 15FEB2022 REPORTED THAT AN EXPERIENCED SENIOR SURGEON SLASHED HER FINGER (1 CM LONG), WHEN TRYING TO REMOVE THE PLASTIC PROTECTIVE SHEATH ON THE 11-BLADE THAT COMES WITH THE PEG KIT 24F; REPORTEDLY, IT WAS ON TOO TIGHTLY AND WAS VERY HARD TO TAKE OFF. THE SURGEON WAS EVALUATED BY THE OCCUPATIONAL HEALTH DEPARTMENT AND SUTURES WERE RECOMMENDED; THE SURGEON DECIDED TO MANAGE THE CUT WITH DERMABOND/STERI-STRIPS AFTER THE BLEEDING WAS CONTROLLED WITH PROLONGED PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2758517 MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 24 FR - PULL DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 7180-24 UNKNOWN 00350770409832

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other