BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN 4-LAYER TISSUE GRAFT

    MDR report key: 3800409 · Received April 3, 2014

    Report

    Report Number
    1835959-2014-00076
    Event Type
    Injury
    Date Received
    April 3, 2014
    Report Date
    January 7, 2016
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K980431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPDATE: THE ROOT CAUSE OF THE PATIENT¿S DYSPAREUNIA IS INCONCLUSIVE, BUT NOT BELIEVED TO BE DIRECTLY RELATED TO THE IMPLANTATION OF THE SURGISIS 4-LAYER TISSUE GRAFT. CONTRIBUTING FACTORS TO THE PATIENT¿S DYSPAREUNIA LIKELY INCLUDE, BUT IS NOT LIMITED TO, THE FACT THAT THE PATIENT HAD DYSPAREUNIA PRIOR TO THE USE OF SURGISIS, INTERSTITIAL CYSTITIS, AND ENDOMETRIOSIS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT; PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED; PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED. 510(K) UNKNOWN; PRODUCT UNSPECIFIED. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN. CONCLUSION - ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. INVESTIGATION INTO THIS CLAIM INCLUDED A REVIEW OF THE CLAIM ALLEGATION 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 SOFT TISSUE 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 A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH SURGISIS BIODESIGN SOFT TISSUE GRAFT ON (B)(6) 2004, AT (B)(6) HOSPITAL, (B)(6) BY DR. (B)(6) TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. THE PATIENT 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 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.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH SURGISIS BIODESIGN SOFT TISSUE GRAFT ON (B)(6) 2004, AT (B)(6) TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE. THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS PRODUCT BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE CORRECTIVE SURGERY. UPDATE: ON (B)(6) 2004, (B)(6) IMPLANTED A SURGISIS 4-LAYER TISSUE GRAFT INTO THE PATIENT FOR REPAIR OF A SYMPTOMATIC CYSTOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200546 BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES FTM COOK BIOTECH NA UNSPECIFIED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability