BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAL ADHESIVE SPRAY

    MDR report key: 7564987 · Received June 1, 2018

    Report

    Report Number
    MW5077603
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    February 9, 2018
    Report Date
    May 22, 2018
    Manufacturer
    HYPERBRANCH MEDICAL TECHNOLOGY INC.
    Product Code
    NQR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MY (B)(46 SON HAD CHIARI DECOMPRESSION ON (B)(6) 2018. NEUROSURGEON USED ADHESIVE SPRAY (MADE BY (B)(4)) ON MY SON'S PATCH AND THE GLUE ATE A HOLE THROUGH THE PATCH AND THEN CREATED A SEVERE CSF LEAK WHICH CAUSED A 19 DAY HOSPITAL STAY WITH MULTIPLE MRIS. IV'S, HYDROCEPHALUS, BRAIN DRAIN AND ANOTHER SURGERY TO FIX PATCH! THIS COMPANY SHOULD BE HELD RESPONSIBLE! MY SON IS SCARRED AND WAS PUT THROUGH A LOT OF UNNECESSARY PAIN! DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: YES. DID THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2018. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2018. SEE SCANNED PAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405893 DURAL ADHESIVE SPRAY SEALANT, DURAL NQR HYPERBRANCH MEDICAL TECHNOLOGY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| L