BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADHERUS AUTOSPRAY

    MDR report key: 8684750 · Received June 10, 2019

    Report

    Report Number
    0008010177-2019-00033
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 10, 2019
    Manufacturer
    HYPERBRANCH MEDICAL TECHNOLOGY, INC
    Product Code
    NQR
    PMA / PMN Number
    P130014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER HAD PERFORMED A CRANIOTOMY AND A REVISION SURGERY NEEDED TO BE COMPLETED DUE TO A CSF LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477109 ADHERUS AUTOSPRAY IMPLANT NQR HYPERBRANCH MEDICAL TECHNOLOGY, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other