BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN 4 LAYER TISSUE GRAFT

    MDR report key: 4101710 · Received August 28, 2014

    Report

    Report Number
    1835959-2014-00930
    Event Type
    Injury
    Date Received
    August 28, 2014
    Report Date
    August 27, 2014
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTM
    PMA / PMN Number
    K980431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 ATTY. BASED ON THE INFO PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE SURGIS ES SOFT TISSUE GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAINS UNK. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. ALL OTHER MATTERS RELATING TO THIS LITIGATION ARE BEING HANDLED BY OUR ATTY. IF / WHEN ADDITIONAL INFO IS OBTAINED A FOLLOW UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH A BARD AVAULTA PLUS ANTERIOR SUPPORT SYSTEM AND A BARD AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM ON (B)(6) 2009 AND A SURGIS ES SOFT TISSUE GRAFT ON (B)(6) 2010. BOTH SURGERIES TOOK PLACE AT (B)(6) AND WERE PERFORMED BY DR. (B)(6). THE PATIENT AND HER ATTY HAVE ALLEGED THAT ASA RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT. THE FOLLOWING INFO WAS NOT PROVIDED BY THE COMPLAINANT: SPECIFIC INFO OF THE ALLEGED INJURY, SPECIFIC INFO REGARDING WHETHER INTERVENTION WAS PERFORMED, SPECIFIC INFO REGARDING WHY INTERVENTIONS 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
    526527 BIODESIGN 4 LAYER TISSUE GRAFT SURGIS ES FTM COOK BIOTECH, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability BARD AVAULTA PLUS ANTERIOR SUPPORT SYSTEM| IMPLANTED:| IMPLANTED:| BARD AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT| SYSTEM