BEUDAMED
    FDA Adverse Event Summary report: N

    ADHERUS AUTOSPRAY DURAL SEALANT

    MDR report key: 5669428 · Received May 20, 2016

    Report

    Report Number
    3005920920-2016-00001
    Date Received
    May 20, 2016
    Date of Event
    November 20, 2015
    Report Date
    May 19, 2016
    Manufacturer
    HYPERBRANCH MEDICAL TECHNOLOGY, INC.
    Product Code
    NQR
    PMA / PMN Number
    P130014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVALUATION. DEVICE 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. DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT HAD A CHIARI TO DECOMPRESS A CONGENITAL VERTEBRAL ABNORMALITY. PATIENT HAD AN ALLEGED CSF LEAK. RE-EXPLORATION ON (B)(6) 2015 TO CLOSE LEAK. PATIENT BACK TO BASELINE, NO FURTHER ISSUES. HYPERBRANCH PRODUCT IS NOT SUSPECTED TO BE A CONTRIBUTORY CAUSE OF CSF LEAK. NO REPORTED ISSUES MIXING OR APPLYING HYPERBRANCH PRODUCT. SURGEON INDICATED THAT A CSF LEAK IS A COMMON OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324393 ADHERUS AUTOSPRAY DURAL SEALANT DURAL SEALANT NQR HYPERBRANCH MEDICAL TECHNOLOGY, INC. NUS-106 05151534

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR