BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN SURGISIS TENSION FREE URETHRAL SLING

    MDR report key: 3256768 · Received July 29, 2013

    Report

    Report Number
    1835959-2013-00061
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 26, 2013
    Manufacturer
    COOK BIOTECH
    Product Code
    PAG
    PMA / PMN Number
    K020654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT FOR THE TENSION-FREE URETHRAL SLING OR THE UNSPECIFIED SURGISIS BIODESIGN GRAFT. PRODUCT EXPIRE DATE UNKNOWN AS LOT NUMBERS NOT PROVIDED BY THE COMPLAINANT FOR THE TENSION-FREE URETHRAL SLING OR THE UNSPECIFIED SURGISIS BIODESIGN GRAFT. SURGEON NAME NOT PROVIDED BY THE COMPLAINANT. PRODUCT MFR DATE UNKNOWN AS LOT NUMBERS NOT PROVIDED BY THE COMPLAINANT FOR THE TENSION-FREE URETHRAL SLING OR THE UNSPECIFIED SURGISIS BIODESIGN GRAFT. CONCLUSIONS: ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. INVESTIGATION INTO THIS CLAIM HAS INCLUDED A REVIEW OF THE CLAIM ALLEGATIONS, A REVIEW OF THE CBI COMPLAINT SYSTEM 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 SURGISIS TENSION-FREE VAGINAL SLING'S AND THE UNSPECIFIED SURGISIS BIODESIGN GRAFT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE OF THE CLAIM ALLEGATION 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, THAT ALTERS OUR CONCLUSION TO THIS COMPLAINT, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH AN AMS IN-FAST ULTRA (LOT NO. 8422895) AND A SURGISIS TENSION-FREE VAGINAL SLING AND AN UNSPECIFIED SURGISIS BIODESIGN ON (B)(6) 2010 TREAT HER STRESS URINARY INCONTINENCE AND PROLAPSE. THE PATIENT REPORTEDLY UNDERWENT ANOTHER SURGERY ON (B)(6) 2012 AND WAS IMPLANTED WITH A JOHNSON AND JOHNSON, ETHICON, INC. AND ETHICON, LLC TVT DEVICE (REFERENCE NO. 810041B AND LOT NO. 35321010). THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PATIENT, THE PATIENT EXPERIENCED PAIN, INJURY, AND UNDERWENT ADDITIONAL SURGERY. 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
    353279 BIODESIGN SURGISIS TENSION FREE URETHRAL SLING SURGISIS TENSION FREE URETHRAL SLING PAG COOK BIOTECH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability TVT DEVICE: REF #80041B, LOT #35321010 JOHNSON AND| AMP, JOHNSON, ETHICON, INC. AND ETHICON, LLC| AMS IN-FAST: LOT #8422895| AN UNSPECIFIED SURGISIS BIODESIGN GRAFT