BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADHERUS AUTOSPRAY ET DURAL SEALANT

    MDR report key: 20965348 · Received December 18, 2024

    Report

    Report Number
    3005920920-2024-00002
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    November 28, 2024
    Report Date
    June 5, 2025
    Manufacturer
    HYPERBRANCH MEDICAL TECHNOLOGY, INC
    Product Code
    NQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED: D9. ADDITIONAL INFORMATION: H6. ALTHOUGH THE OBSERVATION MADE IN THE REPORTED INCIDENT THAT THE HYDROGEL WAS APPLIED UNEVENLY WAS CONFIRMED, THE INSPECTION OF THE RETURNED DEVICE DID NOT REVEAL ANY EVIDENCE OF A MALFUNCTIONING DEVICE. THE DEVICE HAD BEEN USED SUCCESSFULLY FOR SEVERAL YEARS, BUT DURING THE PROCEDURE THERE WAS INCONSISTENT APPLICATION AND A SHORT SURGICAL DELAY DUE TO UNEVEN MIXING OF THE GEL, SO A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. A THOROUGH REVIEW OF MANUFACTURING AND QUALITY RECORDS REVEALED NO ISSUES AND THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. BASED ON THE INVESTIGATION STEPS PERFORMED, NO PRODUCT ISSUE INDICATING NONCONFORMITY, UNFAVORABLE TREND OR UNEXPECTED HAZARD/HARM HAS BEEN IDENTIFIED. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE PRODUCT ASSEMBLY, WHEN APPLYING TO THE DURA MATER, IT BECAME A LUMP AND COULD NOT BE SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082374 ADHERUS AUTOSPRAY ET DURAL SEALANT DURAL SEALANT NQR HYPERBRANCH MEDICAL TECHNOLOGY, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention