BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN SURGISIS ANTERIOR PELVIC FLOOR GRAFT

    MDR report key: 3271148 · Received August 2, 2013

    Report

    Report Number
    1835959-2013-00088
    Event Type
    Injury
    Date Received
    August 2, 2013
    Report Date
    July 31, 2013
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    PAJ
    PMA / PMN Number
    K130006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 HAS 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 SURGISIS ANTERIOR PELVIC FLOOR GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. 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 ATTORNEY. IF/ WHEN ADDITIONAL INFORMATION IS OBTAINED, THAT ALTERS OUR CONCLUSION TO THIS COMPLAINT, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH A PROLIFT TVT (810041B, LOT 1083223) ON (B)(6) 2003, AT (B)(6) OF (B)(6). THE PATIENT WAS ALSO REPORTEDLY IMPLANTED WITH A SURGISIS (LOT LB537641) ON (B)(6) 2012 AT (B)(6) HOSPITAL IN (B)(6). THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS PRODUCT BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN AND INJURY. 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
    362334 BIODESIGN SURGISIS ANTERIOR PELVIC FLOOR GRAFT ANTERIOR PELVIC FLOOR GRAFT PAJ COOK BIOTECH, INC. NA LB537641

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability PROLIFT TVT: 810041B, LOT 1083223 AT (B)(6)| (B)(6)