BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN PATCH

    MDR report key: 6986684 · Received October 30, 2017

    Report

    Report Number
    MW5073023
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    October 1, 2017
    Report Date
    October 25, 2017
    Manufacturer
    INTEGRA LIFE SCIENCES
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY DAUGHTER IS (B)(6). SHE HAD A DECOMPRESSION SURGERY DONE AT (B)(6) HOSPITAL IN (B)(6). WITH THE DURAGEN FROM COLLAGEN MATRIX AND STRYKER. I THINK THAT'S WHAT THE HOSPITAL SAID ABOUT THE PATCH. SHE HAD IT PUT IN ON THE FIRST AND BY THE 10TH OF THE MONTH THE PATCH HAD ALREADY DISINTEGRATED. WE BROUGHT HER BACK TO THE ER 24 HOURS AFTER HER RELEASE FROM THE HOSPITAL. IN THE ER HER BLOOD WORK CAME BACK THAT SHE HAD AN INFECTION. ALSO BY THIS TIME HER INCISION ON THE BACK OF HER HEAD WAS OPEN AND CSF FLUID AND PUSS WAS POURING OUT. THE NEUROSURGEON SAID SHE HAD TO GO IN TO EMERGENCY SURGERY TO CLEAN IT UP. AFTER THE SURGERY THE SURGEON CAME OUT AND SAID THAT THE PATCH DISINTEGRATED AND HE NEVER SEEN IT HAPPEN BEFORE. ALSO A BAD INFECTION HAD STARTED IN HER HEAD. HE CONTACTED THE REPRESENTATIVE AT STRYKER MEDICAL SUPPLIES AND THEY CAME TO GET THE PATCH AND ALL THE BATCH NUMBER AND TO INVESTIGATE WHAT HAPPENED. BOTH SURGEONS HAVE CALLED AND TRIED TO FIND OUT WHAT HAPPENED. THEY THINK IT WAS A BAD PATCH WHICH RESULTED IN AN EMERGENCY SURGERY TO REMOVE WHAT WAS LEFT AND TO PUT A DIFFERENT ONE. I HOPE YOU ALL CAN HELP US GET ANSWERS. SHE WAS IN THE HOSPITAL 21 DAYS TOTAL WITH THE PIC LINE FOR 14 DAYS TO KILL THE (B)(6) INFECTION AND THE OTHER INFECTION. THANK YOU. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766038 DURAGEN PATCH COLLAGEN MATRIX GXQ INTEGRA LIFE SCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| R| S