BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN SURGISIS TENSION FREE URETHRAL SLING

    MDR report key: 3080009 · Received April 24, 2013

    Report

    Report Number
    1835959-2013-00034
    Event Type
    Injury
    Date Received
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    COOK BIOTECH
    Product Code
    PAG
    PMA / PMN Number
    K020654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT MANUFACTURE DATE UNK AS LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. 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 WAS HANDLED BY OUR ATTORNEY. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE TENSION-FREE URETHRAL SLING'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 INFORMATION IS OBTAINED THAT ALTERS OUR CONCLUSION TO THIS COMPLAINT, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH A SURGISIS BIODESIGN TENSION-FREE URETHRAL SLING, A STRATASIS TENSION-FREE URETHRAL SLING, AND AN IN-FAST SLING, DURING SURGERY PERFORMED AT (B)(6) HOSPITAL, TO TREAT HER PELVIC ORGAN PROLAPSE AND/OR STRES URINARY INCONTINENCE. THE PT AND HER ATTORNEY ALLEGE THAT AS A RESULT OF HAVING THESE PRODUCTS IMPLANTED IN THE PT, THE PT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE CORRECTIVE 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 WHAT 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
    177786 BIODESIGN SURGISIS TENSION FREE URETHRAL SLING SURGISIS TENSION FREE URETHRAL SLING PAG COOK BIOTECH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability SLINGS. IT IS UNCLEAR IF PRODUCTS WERE PLACED ALL| AT ONCE AS NOT SURGERY DATE(S) WAS PROVIDED.| THE SURGISIS AND STRATASIS TENSION-FREE URETHRAL| REPORTEDLY, IN-FAST SLING WAS USED IN ADDITION TO