BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADHERUS AUTOSPRAY DURAL SEALANT

    MDR report key: 12925268 · Received December 3, 2021

    Report

    Report Number
    0008010177-2021-00051
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    October 20, 2021
    Report Date
    December 3, 2021
    Manufacturer
    HYPERBRANCH MEDICAL TECHNOLOGY, INC
    Product Code
    NQR
    PMA / PMN Number
    P130014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION AFTER SURGERY USING ADHERES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825981 ADHERUS AUTOSPRAY DURAL SEALANT IMPLANT NQR HYPERBRANCH MEDICAL TECHNOLOGY, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other