BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - UNSPECIFIED BY THE COMPLAINANT

    MDR report key: 4012395 · Received July 31, 2014

    Report

    Report Number
    1835959-2014-00276
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 30, 2014
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: CONCLUSION - ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. INVESTIGATION INTO THIS CLAIM INCLUDED A REVIEW OF THE CLAIM ALLEGATIONS AND ALL OTHER COMMUNICATION AND INVESTIGATION INTO THIS REPORT/CLAIM IS BEING HANDLED BY OUR ATTORNEY. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE BIODESIGN OR SURGISIS 4-LAYER GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE DUE TO A 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 EITHICON GYNEMESH/GYNEMESH PS AND AN ETHICON TCT-EXACT ON (B)(6) 2011, BY DR. (B)(6). THE PATIENT WAS IMPLANTED WITH AN UNSPECIFIED SURGISIS PRODUCT ON (B)(6) 2013, BY DR. (B)(6). BOTH SURGERIES TOOK PLACE 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
    447043 UNK - UNSPECIFIED BY THE COMPLAINANT UNK FTM COOK BIOTECH, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability ETHICON GYNEMESH/GYNEMESH PS| ETHICON TVT-EXACT