BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_CMF_PRODUCT

    MDR report key: 21282609 · Received January 31, 2025

    Report

    Report Number
    3005920920-2025-00001
    Event Type
    Injury
    Date Received
    January 31, 2025
    Date of Event
    January 2, 2025
    Report Date
    June 6, 2025
    Manufacturer
    HYPERBRANCH MEDICAL TECHNOLOGY, INC
    Product Code
    NQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6. THE OBSERVATION STATED IN THE REPORTED EVENT COULD NOT BE CONFIRMED. THE ADHERUS DEVICE WAS DISCARDED AFTER SURGERY WITH NO LOT NUMBER OR SAMPLES AVAILABLE, PREVENTING FURTHER INVESTIGATION, SO THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. BASED ON THE INVESTIGATION INCLUDING 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.

    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 THE SURGEON HAD TO TAKE THE PATIENT BACK TO THE OPERATING ROOM THREE WEEKS AFTER THE SURGERY DUE TO A RECURRENT DURA LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2115742 UNKNOWN_CMF_PRODUCT IMPLANT NQR HYPERBRANCH MEDICAL TECHNOLOGY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention