BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADHERUS AUTOSPRAY DURAL SEALANT

    MDR report key: 15233557 · Received August 15, 2022

    Report

    Report Number
    MW5111481
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Report Date
    August 11, 2022
    Manufacturer
    HYPERBRANCH MEDICAL TECHNOLOGY INC
    Product Code
    NQR
    UDI-DI
    00897146002018
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADHERES AUTOSPRAY DURAL SEALANT MALFUNCTIONED AND BECAME STUCK WHEN TRYING TO MIX PRODUCT RESULTING IN ONLY PARTIAL MIXTURE AND INABILITY TO USE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2819417 ADHERUS AUTOSPRAY DURAL SEALANT SEALANT, DURAL NQR HYPERBRANCH MEDICAL TECHNOLOGY INC NUS-106 05224039 00897146002018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown