BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN ANTERIOR PELVIC FLOOR GRAFT

    MDR report key: 5173968 · Received October 24, 2015

    Report

    Report Number
    1835959-2015-00227
    Event Type
    Injury
    Date Received
    October 24, 2015
    Report Date
    October 16, 2015
    Manufacturer
    COOK BIOTECH
    Product Code
    FTL
    PMA / PMN Number
    K992159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: BARD URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM: (B)(6) 2005. COOK MEDICAL BIODESIGN ANTERIOR PELVIC FLOOR GRAFT: (B)(6) 2012. NEOMEDIC REMEEX SYSTEM: (B)(6) 2012. BOSTON SCIENTIFIC UPSYLON Y-MESH: (B)(6) 2015.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH A BARD URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM, ON (B)(6) 2005, AT (B)(6) BY DR. (B)(6). THE PATIENT WAS ALSO REPORTEDLY IMPLANTED WITH TWO COOK MEDICAL BIODESIGN ANTERIOR PELVIC FLOOR GRAFTS AND A NEOMEDIC REMEEX SYSTEM, ON (B)(6) 2012, AT THE MEDICAL CENTER OF (B)(6) BY DR. (B)(6). ADDITIONALLY, THE PATIENT WAS REPORTEDLY IMPLANTED WITH A BOSTON SCIENTIFIC UPSYLON Y-MESH, ON (B)(6) 2015, AT THE MEDICAL CENTER (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702634 BIODESIGN ANTERIOR PELVIC FLOOR GRAFT PELVIC FLOOR ANTERIOR FTL COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1