BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN 4-LAYER TISSUE GRAFT

    MDR report key: 4122442 · Received September 18, 2014

    Report

    Report Number
    1835959-2014-00951
    Event Type
    Injury
    Date Received
    September 18, 2014
    Report Date
    February 3, 2016
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K980431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN. UPDATE: THE ROOT CAUSE OF THE PATIENT¿S CURRENT COMPLAINTS IS INCONCLUSIVE. HOWEVER, RECURRENCE AND LACK OF EFFECTIVENESS ARE KNOWN POTENTIAL COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    CONCLUSIONS - 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 BIODESIGN OR SURGISIS 4-LAYER 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 A BIODESIGN OR SURGISIS 4-LAYER TISSUE GRAFT ON (B)(6) 2013 AT (B)(6) HOSPITAL IN (B)(6), BY DR. (B)(6). THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS PRODUCTS BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT. UPDATE: ON (B)(6) 2013, DR. (B)(6) IMPLANTED A SURGISIS 7X10 GRAFT FOR TREATMENT OF THE PATIENT¿S GRADE IV CYSTOCELE AND VAGINAL WALL PROLAPSE. THE PATIENT REPORTED THAT AT APPROXIMATELY THREE TO SIX MONTHS POST SURGERY SHE EXPERIENCED RECURRENT URINARY INCONTINENCE, RECURRENT PROLAPSE, AND VAGINAL PAIN. ON (B)(6) 2014, DR. (B)(6) PERFORMED SURGERY TO REPAIR THE RECURRENT PROLAPSE AND RECURRENT URINARY INCONTINENCE. NO DEVICES WERE IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH A BIODESIGN OR SURGISIS 4-LAYER TISSUE GRAFT ON (B)(6) 2013 AT (B)(6) HOSPITAL, BY DR. (B)(6). THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS 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 ON 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579250 BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES FTM COOK BIOTECH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability