BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD

    MDR report key: 12459497 · Received September 13, 2021

    Report

    Report Number
    12459497
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Date of Event
    August 30, 2021
    Report Date
    August 31, 2021
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    NZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INTEGUSEAL MICROBIAL SEALANT WOULD NOT WORK. NO SOLUTION CAME OUT EVEN AFTER IT WAS POPPED AND OPENED. THE INTEGUSEAL WAS ACCIDENTALLY DISCARDED IN BETWEEN CASES. INTEGUSEAL AND PACKAGING NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356254 HALYARD SEALANT, MICROBIAL NZP AVANOS MEDICAL, INC. 33737 P00219763

    Patients

    Seq Age Sex Outcome Treatment
    1