BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - UNSPECIFIED BY COMPLAINANT

    MDR report key: 4101707 · Received August 28, 2014

    Report

    Report Number
    1835959-2014-00927
    Event Type
    Injury
    Date Received
    August 28, 2014
    Report Date
    August 25, 2014
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. PRODUCT NAME UNK; PRODUCT UNSPECIFIED. PRODUCT COMMON NAME UNK; PRODUCT UNSPECIFIED. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRATION DATE UNK; LOT NUMBER NOT PROVIDED. PRODUCT CATALOG NUMBER UNK, PRODUCT UNSPECIFIED. UNK 510(K); PRODUCT UNSPECIFIED. THE PRODUCT CODE LISTED IS NOT NECESSARILY THE PRODUCT CODE ASSIGNED TO THE DEVICE 510(K), BUT RATHER THE PRODUCT CODE THAT SEEMS THE MOST APPROPRIATE BASED ON THE SURGICAL PROCEDURE IN WHICH THE PRODUCT WAS IMPLANTED. PRODUCT MANUFACTURE DATE UNK; LOT NUMBER UNK. 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 UNSPECIFIED SURGISIS 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 AN ETHICON PROLIFT ON (B)(6) 2001 BY DR. (B)(6). THE PT WAS IMPLANTED WITH AN ETHICON TVT ON (B)(6) 2009 BY DR. (B)(6). THE PT WAS IMPLANTED WITH AN UNSPECIFIED 4X7 SURGISIS GRAFT ON (B)(6) 2013 BY DR (B)(6). THE SURGERIES TOOK PLACE AT (B)(6) HOSP IN (B)(6). THE PATIENT AND HER ATTY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PATIENT, 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
    526490 UNK - UNSPECIFIED BY COMPLAINANT UNK - PRODUCT UNSPECIFIED FTM COOK BIOTECH, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability IMPLANTED:| ETHICON TVT| IMPLANTED:| ETHICON PROLIFT