BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - UNSPECIFIED BY COMPLAINANT

    MDR report key: 4101705 · Received August 28, 2014

    Report

    Report Number
    1835959-2014-00925
    Event Type
    Injury
    Date Received
    August 28, 2014
    Report Date
    August 25, 2014
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    PAG
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. THIS MDR IS RELATED TO MDR 1835959-2014-00926 AND IS FOR PRODUCT 1 OF 2. 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 UNSPECIFIED SURGISIS 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 PT WAS REPORTEDLY IMPLANTED WITH A BOSTON SCIENTIFIC ADVANTAGE FIT SYSTEM AND A SURGIS TISSUE GRAFT BOTH ON (B)(6) 2008 AND (B)(6) 2014. THE SURGERIES TOOK PLACE AT (B)(6) AND WERE PERFORMED BY DR (B)(6). THE PT AND HER ATTY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PT, THE PT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MED 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
    526523 UNK - UNSPECIFIED BY COMPLAINANT UNK - PRODUCT UNSPECIFIED PAG COOK BIOTECH, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability IMPLANTED:| BOSTON SCIENTIFIC ADVANTAGE FIT SYSTEM| BOSTON SCIENTIFIC ADVANTAGE FIT SYSTEM| IMPLANTED: