BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN URETHRAL SLING

    MDR report key: 4170557 · Received October 9, 2014

    Report

    Report Number
    1835959-2014-00965
    Event Type
    Injury
    Date Received
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    COOK BIOTECH, INC.
    Product Code
    PAG
    PMA / PMN Number
    K992159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD AND RESULTS: PRODUCT NOT RETURNED TO CBI. 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 THE STRATASIS URETHRAL SLING'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 STRATASIS URETHRAL SLING ON (B)(6) 2004 AT (B)(6). THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS PRODUCT 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 AND ALLEGED INJURY; CURRENT PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636863 BIODESIGN URETHRAL SLING SURGISIS URETHRAL SLING PAG COOK BIOTECH, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability NONE REPORTED BY THE COMPLAINANT