BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADHERUS AUTOSPRAY ET DURAL SEALANT

    MDR report key: 20558655 · Received October 29, 2024

    Report

    Report Number
    3005920920-2024-00001
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    September 28, 2024
    Report Date
    June 4, 2025
    Manufacturer
    HYPERBRANCH MEDICAL TECHNOLOGY, INC
    Product Code
    NQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE OBSERVATION STATED IN THE REPORTED EVENT COULD NOT BE CONFIRMED. NO MEDICAL INTERVENTION OR PERMANENT HARM WAS OBSERVED, AND THE DEVICE WAS NOT RETURNED; ALTHOUGH THERE HAVE BEEN ISSUES TURNING ON THE PRIMARY DEVICE¿S AIR PUMP, A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE, AFTER WHICH THE PATIENT EXPERIENCED A CSF LEAK. A THOROUGH REVIEW OF MANUFACTURING AND QUALITY RECORDS FOUND NO DEVIATIONS OR ISSUES, AND OVERALL, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. BASED ON THE INVESTIGATION INCLUDING A STATISTICAL ANALYSIS THERE IS NO INDICATION THAT THE PRODUCT IS NOT WORKING AS INTENDED OR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE EXISTS. THEREFORE, NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THAT TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY BUTTON DID NOT WORK AS INTENDED. THE NEXT DAY A CSF LEAKAGE STARTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERY BUTTON DID NOT WORK AS INTENDED. THE NEXT DAY A CSF LEAKAGE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322196 ADHERUS AUTOSPRAY ET DURAL SEALANT IMPLANT NQR HYPERBRANCH MEDICAL TECHNOLOGY, INC 10235195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention