BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN URETHRAL SLING

    MDR report key: 3256700 · Received July 29, 2013

    Report

    Report Number
    1835959-2013-00060
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    October 16, 2015
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    PMA / PMN Number
    K992159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE WAS NOT RETURNED TO THE MANUFACTURER. 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, A REVIEW OF THE DEVICE HISTORY RECORDS, WHICH INDICATED THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS, A REVIEW OF THE SURGISIS BIODESIGN RECTO-VAGINAL FISTULA PLUG IFU (B)(4) AND ALL OTHER COMMUNICATION AND INVESTIGATION INTO THIS REPORT/CLAIM IS BEING HANDLED BY OUR ATTORNEY. THE COMPLAINANT NOTED THE COOK MANUFACTURED PRODUCT TO BE THE "STRATASIS URETHRAL COLPOPEXY Y-SLING (REF. NO. (B)(4), LOT NO. 373991)." THE "STRATASIS URETHRAL COLPOPEXY Y-SLING" AND THE "REF. NO . (B)(4)" NOTED ARE NOT RECOGNIZED AS A COOK BIOTECH INC PRODUCT NAME OR REFERENCE NUMBER. HOWEVER, THE "LOT NO. 373991" WAS FOUND IN OUR SYSTEM TO BELONG TO A COOK SURGISIS BIODESIGN RECTO-VAGINAL FISTULA PLUG. THE PRODUCT LOT WAS MANUFACTURED IN THE YEAR 2008 AND IT APPEARS TO HAVE BEEN SHIPPED TO COOK (B)(4); THESE FACTS DO NOT COINCIDE WITH THE COMPLAINANT'S SURGERY DATE OF (B)(6) 2004. IN ADDITION, A SIMPLE INTERNET SEARCH INDICATED THAT AMERICAN MEDICAL SYSTEMS (AMS) HAS A PRODUCT NAMED "AMS SACRAL COLPOPEXY SLING" WITH A MODEL NUMBER OF 72403501 (WHICH IS THE REFERENCE NUMBER THE COMPLAINANT LISTED AS FOR THE COOK MANUFACTURED PRODUCT) AND 510(K) K010931. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE SURGISIS BIODESIGN RECTO-VAGINAL FISTULA PLUG'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 AND LACK OF CLARITY IN THE DETAILS THAT WERE 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. PRODUCT COMMON NAME IS SURGICAL MESH; PRODUCT CODE IS PAG, PAJ, FTM. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED. PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH AN AMS STRAIGHT-IN SYSTEM (REF. NO. (B)(4), LOT NO. 372488) AND SCREWS (LOT NO. 374267) AND A STRATASIS URETHRAL COLPOPEXY Y-SLING (REF. NO. (B)(4) LOT NO. 373991), ON OR ABOUT (B)(6) 04, TO TREAT HER STRESS URINARY INCONTINENCE AND PROLAPSE. THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INFECTION, WORSENED INCONTINENCE, URINARY PROBLEMS, DYSPAREUNIA, EROSION, THE NEED FOR ADDITIONAL SURGERIES. UPDATE: THE PATIENT WAS REPORTEDLY IMPLANTED WITH A STRATASIS URETHRAL SLING ON (B)(6) 2004, AT (B)(6) MEDICAL CENTER IN (B)(6), BY DR. (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.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTED IMPLANTED WITH AN AMS STRAIGHT-IN SYSTEM (REF. NO. (B)(4), LOT NO. 372488) AND SCREWS (LOT NO. 374267) AND A STRATASIS URETHRAL COLPOPEXY Y-SLING (REF NO. (B)(4), LOT NO. 373991), ON OR ABOUT (B)(6) 2004, TO TREAT HER STRESS URINARY INCONTINENCE AND PROLAPSE. THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THESE PRODUCTS BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INFECTION, WORSENED INCONTINENCE, URINARY PROBLEMS, DYSPAREUNIA, EROSION, THE NEED FOR ADDITIONAL SURGERIES. THE FOLLOWING INFORMATION WAS NOT PROVIDED BY THE COMPLAINANT: SPECIFIC INFORMATION OF THE ALLEGED INJURY, SPECIFIC INFORMATION REGARDING WHETHER INTERVENTION WAS PERFORMED, SPECIFICATION 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
    352927 BIODESIGN URETHRAL SLING RECTAL VAGINAL PLUG FTM COOK BIOTECH LB373991

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability SCREWS: LOT #374267