BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_CMF DURHAM_PRODUCT

    MDR report key: 22058554 · Received May 21, 2025

    Report

    Report Number
    3005920920-2025-00003
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 22, 2025
    Report Date
    June 10, 2025
    Manufacturer
    HYPERBRANCH MEDICAL TECHNOLOGY, INC
    Product Code
    NQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    ADDITIONAL INFORMATION: H6. THE OBSERVATION STATED IN THE REPORTED EVENT COULD NOT BE CONFIRMED. THE REPORTED EVENT OCCURRED ABOUT FIVE YEARS PRIOR, AND DUE TO LIMITED STAFF RECOLLECTION AND LACK OF LOT AND CATALOG NUMBERS, KEY PRODUCT DETAILS AND BATCH RECORDS COULD NOT BE REVIEWED OR TESTED. CONSEQUENTLY, THE ROOT CAUSE OF THE EVENT REMAINS UNDETERMINED BASED ON THE AVAILABLE INFORMATION. BASED ON THE INVESTIGATION INCLUDING A STATISTICAL ANALYSIS, THERE IS NO INDICATION FOR AN INCORRECTLY WORKING PRODUCT OR ANY DESIGN, MATERIAL, OR MANUFACTURING-RELATED ISSUE. THEREFORE, NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. THE DEVICE APPEARED TO BE DETACHED FROM THE DURA AND WAS NOT PROVIDING ANY SEAL AT ALL.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80548 UNKNOWN_CMF DURHAM_PRODUCT DURAL SEALANT NQR HYPERBRANCH MEDICAL TECHNOLOGY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention