BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADHERUS AUTO SPRAY ET DURAL SEALANT

    MDR report key: 20598628 · Received November 1, 2024

    Report

    Report Number
    MW5162086
    Event Type
    Malfunction
    Date Received
    November 1, 2024
    Date of Event
    October 22, 2024
    Report Date
    October 30, 2024
    Manufacturer
    STRYKER / HYPERBRANCH MEDICAL TECHNOLOGY, INC.
    Product Code
    NQR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6)2024 AROUND 4:40PM AN EXPIRED PRODUCT WAS KNOWINGLY UTILIZED ON A PATIENT, DURING A MICRODISCECTOMY WITH A DURAL TEAR. SURGEON WANTED TO USE ADHERUS AUTOSPRAY ET DURAL SEALANT, TWO PACKAGES OF IN DATE PRODUCT WAS OPENED, THE SPRAYER PORTION OF THE PRODUCT WAS THOUGHT TO MALFUNCTION. FIRST PRODUCT DID NOT TURN ON AT ALL, THE OTHER, THE POWER WAS INTERMITTENT. THE SURGEON DID NOT FEEL LIKE HE COULD REPAIR THE TEAR WITH DURAGEN OR UTILIZE SUTURE TO CLOSE THE TEAR, DUE TO THE LOCATION OF TEAR. THERE WAS AN EXPIRED ADHERUS ON THE SHELF AND IT WAS UTILIZED AND FUNCTIONED. REF REPORTS: MW5162084, MW5162085.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461680 ADHERUS AUTO SPRAY ET DURAL SEALANT SEALANT, DURAL NQR STRYKER / HYPERBRANCH MEDICAL TECHNOLOGY, INC. NUS-109

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female