BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADHERUS DURAL SEALANT

    MDR report key: 7502238 · Received May 9, 2018

    Report

    Report Number
    MW5077108
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    February 26, 2018
    Report Date
    May 7, 2018
    Manufacturer
    HYPERBRANCH MEDICAL TECHNOLOGY, INC.
    Product Code
    NQR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY (B)(6) DAUGHTER WAS DIAGNOSED WITH CHIARI MALFORMATION AND UNDERWENT A DECOMPRESSION SURGERY. A BOVINE PATCH WAS INSTALLED TO HER DURA MATER AND APPROXIMATELY FIVE OR SIX WEEKS LATER SHE EXPERIENCED SEVERE SWELLING IN THE AREA WHERE THE PATCH WAS INSTALLED. SURGERY ENSUED AND IT WAS DETERMINED - BY STATEMENTS MADE BY HER NEUROSURGEON - THAT AN ADHESIVE PLACED ON THE PATCH, CALLED ADHERUS, HAD REACTED TO THE PATCH AND HAD CHEWED A HOLE THROUGH THE PATCH. THE HOLE IN THE PATCH ALLOWED CEREBRAL SPINAL FLUID TO ESCAPE, GAVE HER MASSIVE HEADACHES AND INCREASED HER RISK OF INFECTION. SHE WAS HOSPITALIZED FOR AN EXTENDED PERIOD, HAS UNDERGONE OVER A DOZEN MRIS, EXPERIENCED HYDROCEPHALUS AND STILL HAS EXCESSIVE CEREBRAL SPINAL FLUID ACCUMULATION AT THE BASE OF HER SKULL. A FAMILY IN THE PICU ROOM NEXT TO OURS, WHOSE 3 YEAR OLD SON ALSO UNDERWENT A DECOMPRESSION SURGERY, HAD TO HAVE A CORRECTIVE SURGERY AS A HOLE WAS ALSO DISCOVERED IN HIS PATCH. WE WERE TOLD THAT THE HOLE WAS ALSO CAUSED BY THE ADHESIVE. DATES OF USE: (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: THE PRODUCT IS A SEALANT TO BE USED DURING BRAIN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342956 ADHERUS DURAL SEALANT SEALANT, DURAL NQR HYPERBRANCH MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| O| S