BEUDAMED
    FDA Adverse Event Summary report: N

    ADHERUS AUTOSPRAY DURAL SEALANT

    MDR report key: 5669451 · Received May 20, 2016

    Report

    Report Number
    3005920920-2016-00002
    Date Received
    May 20, 2016
    Date of Event
    March 25, 2016
    Report Date
    May 19, 2016
    Manufacturer
    HYPERBRANCH MEDICAL TECHNOLOGY INC.
    Product Code
    NQR
    PMA / PMN Number
    P130014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVALUATION. UNIT WAS DISPOSED OF BY HEALTHCARE FACILITY. HYPERBRANCH COMPLETED ITS INTERNAL INVESTIGATION ON 19-MAY-2016. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN PERFORMED. THIS REVIEW CONFIRMED THAT THIS LOT OF PRODUCT WAS REVIEWED AND RELEASED ACCORDING TO QA SPECIFICATIONS. A REVIEW OF HISTORICAL COMPLAINT DATA DISPLAYED NO INCREASE IN TRENDS. A RETAIN UNIT OF THE SAME LOT WAS TESTED AND FOUND TO CONFORM TO SPECIFICATIONS. CONCLUSION: THE PRODUCT IN QUESTION WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE SPECIFIC CAUSE FOR THE PROBLEM REPORTED COULD NOT BE IDENTIFIED. IF ADDITIONAL INFORMATION IS OBTAINED, OR THE SAMPLE IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    DURING A CHIARI PROCEDURE, BUBBLES OBSERVED IN HYDROGEL UPON APPLICATION. HYDROGEL WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323781 ADHERUS AUTOSPRAY DURAL SEALANT DURAL SEALANT NQR HYPERBRANCH MEDICAL TECHNOLOGY INC. NUS-106 05151534

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR