BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN 4-LAYER TISSUE GRAFT

    MDR report key: 4092158 · Received August 21, 2014

    Report

    Report Number
    1835959-2014-00920
    Event Type
    Injury
    Date Received
    August 21, 2014
    Report Date
    November 24, 2015
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K980431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMMON NAME IS SURGICAL MESH; PRODUCT CODE IS FTM. MFG DATE: PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN. UPDATE: BASED ON A REVIEW OF THE ADDITIONAL DETAILS RECEIVED, THE ROOT CAUSE OF THE PATIENT'S ALLEGATIONS REMAINS INCONCLUSIVE. THE BIODESIGN 4-LAYER TISSUE GRAFT APPEARS TO HAVE PERFORMED AS INTENDED IN REPAIRING THE PATIENT'S CYSTOCELE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ATTORNEY. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE UNSPECIFIED SURGISIS PRODUCT'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 A BIODESIGN OR SURGISIS 4-LAYER TISSUE GRAFT ON (B)(6) 2011 AT (B)(6), BY DR (B)(6). 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 NAD ALLEGED INJURY, CURRENT PATIENT STATUS.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH A BIODESIGN OR SURGISIS 4-LAYER TISSUE GRAFT ON (B)(6) 2011 AT (B)(6). 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. UPDATE: THE (B)(6) 2011 SURGERY WAS A PUBOVAGINAL SLING PROCEDURE AND CYSTOCELE REPAIR WITH THE BIODESIGN 4-LAYER TISSUE GRAFT. THE PATIENT REPORTED THAT AFTER THE 2011 SURGERY, HER URINARY INCONTINENCE RESOLVED. IN (B)(6) 2012, THE PATIENT WAS SEEN FOR COMPLAINTS OF VAGINAL PRESSURE. DR. (B)(6) NOTED THAT THERE WAS ACCEPTABLE ANTERIOR BLADDER SUPPORT, PRESENCE OF A RECTOCELE, AND TENDERNESS WITH EXAM. A FEW WEEKS LATER THE PATIENT WAS DIAGNOSED WITH A RIGHT OVARIAN CYST. SHE INDICATED SHE HAD A PAINFUL PAP SMEAR IN (B)(6) 2014 AND THEN HAD URINARY LEAKING FOR APPROXIMATELY ONE YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504574 BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES FTM COOK BIOTECH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability