BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN 4-LAYER TISSUE GRAFT

    MDR report key: 6053410 · Received October 25, 2016

    Report

    Report Number
    1835959-2016-00628
    Event Type
    Injury
    Date Received
    October 25, 2016
    Report Date
    October 24, 2016
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    UDI-DI
    10827002466125
    PMA / PMN Number
    K980431
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS - ETHICON GYNEMESH PS GPSLL02 / LOT TMP223 ON (B)(6) 2005, (B)(6) 2012; A BOSTON SCIENTIFIC ADVANTAGE SLING SYSTEM M0068502000 / LOT OML4010702 ON (B)(6) 2005, (B)(6) 2012; AN ETHICON GYNECARE TVT-OBTURATOR 810081 / LOT 3621918 ON (B)(6) 2005, (B)(6) 2012. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THREE DEVICES WERE PRODUCED FROM THIS LOT NUMBER. A REVIEW OF THE CBI COMPLAINT DATABASE DID NOT REVEAL ANY OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT¿S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE DUE TO THE LACK OF DETAILS PROVIDED BY THE COMPLAINANT. ALL OTHER MATTERS RELATING TO THIS LITIGATION ARE BEING HANDLED BY OUR ATTORNEY. A FOLLOW-UP MDR WILL BE FILED IF ADDITIONAL DETAILS ARE OBTAINED.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH AN ETHICON GYNEMESH PS GPSLL02 / LOT TMP223, A BOSTON SCIENTIFIC ADVANTAGE SLING SYSTEM M0068502000 / LOT OML4010702, A SURGISIS G46612 / LOT LB504357, AND AN ETHICON GYNECARE TVT-OBTURATOR 810081 / LOT 3621918. THE COMPLAINANT LISTED PROCEDURE DATES OF (B)(6) 2005, (B)(6) 2012, BUT DID NOT NOTE WHICH PRODUCTS WERE IMPLANTED ON A DATE. THE PROCEDURES TOOK PLACE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705683 BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES FTM COOK BIOTECH 10827002466125

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability