BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN 4-LAYER TISSUE GRAFT

    MDR report key: 3800346 · Received April 3, 2014

    Report

    Report Number
    1835959-2014-00133
    Event Type
    Injury
    Date Received
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    FTM
    PMA / PMN Number
    K980431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRE DATE UNK; LOT NUMBER WAS NOT PROVIDED. PRODUCT MFR DATE UNK. CONCLUSIONS - ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. MDR IS RELATED TO MDR #1835959-2014-00134. 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 BIODESIGN OR 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 F/U MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH A BIODESIGN OR SURGISIS 4-LAYER TISSUE GRAFT ON (B)(6) 2009, AT (B)(6) HOSPITAL IN (B)(6) BY (B)(6) M.D. 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 PT, THE PT 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 PT STATUS. THE PT ALSO HAD ANOTHER PROCEDURE IN WHICH A PRIOR SLING MESH MANUFACTURED BY AMERICAN MEDICAL SYSTEMS WAS REMOVED FROM THE PT. AT THE SAME TIME A BIODESIGN TENSION FREE URETHRAL SLING WAS PLACED ON (B)(6) 2009 AT (B)(6) HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200324 BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES FTM COOK BIOTECH, INC. NA UNSPECIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability