BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANOS

    MDR report key: 12048739 · Received June 23, 2021

    Report

    Report Number
    12048739
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 8, 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

    HALYARD INTEGUSEAL WOULD NOT RELEASE THE FLUID INSIDE. MULTIPLE HAVE COME THIS WAY AND ARE WASTED. NO INTEGUSEAL APPLICATORS WERE SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945419 AVANOS SEALANT, MICROBIAL NZP AVANOS MEDICAL, INC. 33737 P00219763

    Patients

    Seq Age Sex Outcome Treatment
    1