BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN TENSION FREE URETHRAL SLING

    MDR report key: 5857711 · Received August 9, 2016

    Report

    Report Number
    1835959-2016-00310
    Event Type
    Injury
    Date Received
    August 9, 2016
    Report Date
    August 9, 2016
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K020654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT PRODUCTS - BARD MONOFILAMENT KNITTED POLYPROPYLENE MESH ON (B)(6) 2003; AMS IN-FAST ULTRA KIT ON (B)(6) 2011. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE STRATASIS TENSION-FREE URETHRAL SLING¿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 A BARD MONOFILAMENT KNITTED POLYPROPYLENE MESH ON (B)(6) 2003, AT (B)(6), BY DR. (B)(6). ADDITIONALLY, THE PATIENT WAS IMPLANTED WITH AN AMS IN-FAST ULTRA KIT AND A STRATASIS TENSION-FREE URETHRAL SLING 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510468 BIODESIGN TENSION FREE URETHRAL SLING STRATASIS TENSION FREE URETHRAL SLING FTM COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability