BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN SURGISIS TENSION FREE URETHRAL SLING

    MDR report key: 3193548 · Received June 25, 2013

    Report

    Report Number
    1835959-2013-00044
    Event Type
    Injury
    Date Received
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    COOK BIOTECH
    Product Code
    PAG
    PMA / PMN Number
    K020654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE NOT PROVIDED BY THE COMPLAINANT. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNK AS LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. SURGEON NAME NOT PROVIDED BY THE COMPLAINANT. PRODUCT MFR DATE UNK AS LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. EC CONCLUSIONS CODE DESC-1 - 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 INFO PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE STRATASIS TENSION-FREE URETHRAL SLING KIT'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNK. 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 INFO IS OBTAINED, THAT ALTERS OUR CONCLUSION TO THIS COMPLAINT, A FOLLOW-UP MDR WILL BE FIELD.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH A STRATASIS TENSION-FREE URETHRAL SLING KIT, TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRESS URINARY INCONTINENCE, DURING SURGERY PERFORMED AT (B)(6) IN (B)(6) ON (B)(6) 2005. THE PT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS PRODUCT BEING IMPLANTED IN THE PT, THE PT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE CORRECTIVE SURGERY. THE FOLLOWING INFO WAS NOT PROVIDED BY THE COMPLAINANT: SPECIFIC INFO OF THE ALLEGED INJURY; SPECIFIC INFO REGARDING WHETHER INTERVENTION WAS PERFORMED; SPECIFIC INFO REGARDING WHY INTERVENTION WAS PERFORMED OR WHAT TYPE/TO WHAT EXTENT INTERVENTION WAS PERFORMED; SPECIFIC CORRELATION BETWEEN DEVICE PERFORMANCE AND ALLEGED INJURY; CURRENT PT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286955 BIODESIGN SURGISIS TENSION FREE URETHRAL SLING SURGISIS TENSION FREE URETHRAL SLING PAG COOK BIOTECH UNK

    Patients

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