BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN DURAL GRAFT

    MDR report key: 3971189 · Received July 8, 2014

    Report

    Report Number
    1835959-2014-00248
    Event Type
    Injury
    Date Received
    July 8, 2014
    Report Date
    July 7, 2014
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K031850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT.; SURGEON NAME NOT PROVIDED BY THE COMPLAINANT. CONCLUSIONS; ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. INVESTIGATION INTO THIS CLAIM INCLUDED A REVIEW OF THE CLAIM ALLEGATIONS, A REVIEW OF THE DEVICE HISTORY RECORDS WHICH INDICATED THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS, A REVIEW OF THE BIODESIGN SURGISIS DURAL GRAFT IFU FP0030-IG AND ALL OTHER COMMUNICATION AND INVESTIGATION INTO THIS REPORT/CLAIM IS BEING HANDLED BY OUR ATTORNEY. AFTER REVIEWING DEVICE HISTORY RECORDS, IT APPEARS THE REPORTED IMPLANT DATE DOES NOT COINCIDE WITH THE DATE OF MANUFACTURE OF THE REPORTED LOT NUMBER. THE IMPLANT DATE WAS REPORTED AS (B)(6) 2007 AND THE MANUFACTURE OF LOT LB525000 WAS (B)(6) 2011. ADDITIONALLY, THE COMPLAINANT NOTES THE PRODUCTS IMPLANTED IN THE PATIENT ON (B)(6) 2007 WERE "PELVIC MESH PRODUCT(S)." HOWEVER, THE BIODESIGN SURGISIS DURAL GRAFT IFU NOTES THAT THE GRAFT IS INTENDED FOR USE AS A DURAL SUBSTITUTE FOR REPAIRING DURA MATER." BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE BIODESIGN SURGISIS GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE DUE TO THE LACK OF DETAILS PROVIDED BY THE COMPLAINANT. ALL OTHER MATTERS RELATING TO THIS LITIGATION ARE BEING HANDLED BY OUR ATTORNEY. IF/WHEN ADDITIONAL INFORMATION IS OBTAINED A FOLLOW UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH AN ETHICON PROLIFT AND A BIODESIGN SURGISIS GRAFT ON (B)(6) 2007 AT (B)(6). THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT. THE FOLLOWING INFORMATION WAS NOT PROVIDED BY THE COMPLAINANT: SPECIFIC INFORMATION OF THE ALLEGED INJURY; SPECIFIC INFORMATION REGARDING WHETHER INTERVENTION WAS PERFORMED; SPECIFIC INFORMATION REGARDING WHY INTERVENTION WAS PERFORMED OR WHAT TYPE/TO WHAT EXTENT INTERVENTION WAS PERFORMED; SPECIFIC CORRELATION BETWEEN DEVICE PERFORMANCE AND ALLEGED INJURY; CURRENT PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398412 BIODESIGN DURAL GRAFT DURAL GRAFT GXQ COOK BIOTECH, INC. NA LB525000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability ETHICON PROLIFT ON