BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN- UNSPECIFIED BY COMPLAINANT

    MDR report key: 3800365 · Received April 3, 2014

    Report

    Report Number
    1835959-2014-00115
    Event Type
    Injury
    Date Received
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. : 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 INFO PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE COOK SURGISIS GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN 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 ATTORNEY. IF/WHEN ADD'L INFO IS OBTAINED A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH AN ETHICON TVT AND UNSPECIFIED COOK SURGISIS GRAFT ON (B)(6) 2007, AT (B)(6) TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. THE PT 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 INFO WAS NOT PROVIDED BY THE COMPLAINANT: SPECIFIC INFO OF THE ALLEGED INJURY; SPECIFIC INFO REGARDING WHETHER INTERVENTION WAS PERFORMED; SPECIFIC INFO 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
    200622 UNKNOWN- UNSPECIFIED BY COMPLAINANT UNKNOWN PRODUCT UNSPECIFIED FTM COOK BIOTECH, INC. NA UNSPECIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability ETHICON TVT