BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN SURGISIS TENSION FREE URETHRAL SLING

    MDR report key: 2921827 · Received January 14, 2013

    Report

    Report Number
    1835959-2013-00007
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    COOK BIOTECH
    Product Code
    PAG
    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 ALLEGED EVENTS NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPLANTATION NOT CONFIRMED BY COMPLAINANT. THIS MDR IS BEING FILED BEYOND THE 30-DAY REPORTING REQUIREMENT DUE TO OUR INITIAL ASSESSMENT RESULTING IN THE OPINION THAT THE COMPLAINT ALLEGATIONS ARISING FROM THIS LAWSUIT WERE TOO VAGUE AND NOT SPECIFIC ENOUGH TO FORM A CONCLUSIVE DECISION. AFTER FURTHER THOUGHT AND REVIEW, THIS MDR IS BEING FILED. THUS FAR, INVESTIGATION INTO THIS CLAIM HAS INCLUDED: A REVIEW OF THE CLAIM ALLEGATIONS; A REVIEW OF THE CBI COMPLAINT SYSTEM WHICH DID NOT IDENTIFY ANY PREVIOUS COMPLAINTS MATCHING THE PROVIDED DETAILS; A REVIEW OF THE DEVICE HISTORY RECORDS WHICH INDICATED THE PRODUCT WAS MFG TO SPECIFICATIONS; INCIDENT INVESTIGATION COMMITTEE REVIEW OF THE CLAIM AND REPORTABILITY ASSESSMENT; INCIDENT INVESTIGATION COMMITTEE DISCUSSED APPROPRIATE WORDING FOR AN MDR SUBMISSION GIVEN THE VAGUE DETAILS OF THE CLAIM; AND A REVIEW OF THE BIODESIGN SURGISIS TENSION-FREE URETHRAL SLING IFU FP0015-3C. BASED ON THE INFO PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE BIODESIGN DEVICE'S PERFORMANCE AND THE ALLEGED INJURY REMAINS UNK. HOWEVER, BASED ON THE ALLEGATIONS IN THE AMENDED COMPLAINT THAT, ON (B)(6) 2009, THE COMPLAINANT HAD IMPLANTED IN HER A MINIARC SLING SYSTEM MFG BY AMERICAN MEDICAL SYSTEMS, INC ("AMS"), FOR HER STRESS URINARY INCONTINENCE ("SUI"), AND THEN HAD A BIODESIGN TENSION-FREE URETHRAL SLING IMPLANTED ON (B)(6) 2011, WE SPECULATE THAT OUR PRODUCT WAS LIKELY PLACED TO REPAIR DAMAGE FROM THE PREVIOUSLY PLACED AMS PRODUCT OR TO REPAIR A RECURRENCE OF THE PT'S SUI. THE BIODESIGN TENSION-FREE URETHRAL SLING IFU FP0015-3C NOTES THAT "THE FOLLOWING COMPLICATIONS ARE POSSIBLE WITH THE USE OF SURGICAL GRAFT MATERIALS: BLEEDING, INFECTION, ADHESIONS, STERILE EFFUSION, CHRONIC INFLAMMATION, ALLERGIC REACTION, AND DELAYED OR FAILED INCORPORATION OF THE SLING." IN ADDITION, THE IFU STATES THAT "COMPLICATIONS OF ANY SLING PLACEMENT PROCEDURE INCLUDE: VOIDING DYSFUNCTION, BLADDER PERFORATION, DE NOVO URGENCY, EROSION, PERSISTENT INCONTINENCE, URINARY RETENTION, AND URINARY FISTULA. IF CONDITIONS OF INFECTION OR ALLERGIC REACTION CANNOT BE RESOLVED, CONSIDER REMOVAL OF THE SLING." NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME. THE INVESTIGATION INTO THIS REPORT REMAINS ONGOING. IF/WHEN ADDITIONAL INFO IS OBTAINED A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY IMPLANTED WITH THE AMS MINIARC TO TREAT HER STRESS URINARY INCONTINENCE ON OR ABOUT (B)(6)2009 AT (B)(6) MED BY DR (B)(6). ON OR ABOUT (B)(6) 2011, THE PT WAS IMPLANTED WITH A BIODESIGN TENSION FREE URETHRAL SLING TO TREAT HER STRESS URINARY INCONTINENCE AT CENTENNIAL MED CTR IN NASHVILLE TN BY DR TARA ALLEN. THE PT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PT, THE PT HAS EXPERIENCED RECURRENT INFECTIONS, SEVERE PAIN AND EROSION, AND HAS UNDERGONE SUBSEQUENT SURGERIES TO REMOVE THE ERODED MESH. 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
    20560 BIODESIGN SURGISIS TENSION FREE URETHRAL SLING SURGISIS TENSION FREE URETHRAL SLING PAG COOK BIOTECH LB490912

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O| R MINIARC REF NO. (B)(4), LOT# 582520034| AMS MINIARC