BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN URETHRAL SLING

    MDR report key: 3971167 · Received July 8, 2014

    Report

    Report Number
    1835959-2014-00249
    Event Type
    Injury
    Date Received
    July 8, 2014
    Report Date
    November 19, 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

    CONCLUSIONS: ROOT CAUSE INCONCLUSIVE DUE TO LACK OF DETAILS PROVIDED BY THE COMPLAINANT. INVESTIGATION INTO THIS CLAIM INCLUDED A REVIEW OF THE CLAIM ALLEGATIONS, 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 STRATASIS URETHRAL SLING'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE OF THE CLAIM ALLEGATIONS IS INCONCLUSIVE DUE TO THE 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 A FOLLOW UP MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMMON NAME IS SURGICAL MESH; UPDATE: A REVIEW OF THE CBI COMPLAINT SYSTEM DID NOT REVEAL ANY PREVIOUSLY FILED COMPLAINTS THAT MATCH THE DETAILS PROVIDED IN THE CLAIM. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. DUE TO A LACK OF MEDICAL FOLLOW-UP AND DIAGNOSTIC WORKUP, OTHER CONTRIBUTING FACTORS TO THE STRESS URINARY INCONTINENCE AND/OR OTHER TYPES OF CONTRIBUTING URINARY COMPLICATIONS CANNOT BE CONFIRMED OR RULED OUT. AS SUCH, THE ROOT CAUSE OF THE PATIENT'S ALLEGED LACK OF EFFECTIVENESS OF THE STRATASIS URETHRAL SLING IS INCONCLUSIVE. MANY FACTORS COULD CONTRIBUTE TO THIS INCLUDING, BUT NOT LIMITED TO, SURGICAL TECHNIQUE, PATIENT POSTOPERATIVE CARE, AND POSTOPERATIVE ACTIVITY.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH A STRATASIS URETHRAL SLING ON (B)6) 2005, AT (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. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH A STRATASIS URETHRAL SLING ON (B)(6) 2005, AT (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. UPDATE: ON (B)(6) 2005, THE PATIENT UNDERWENT (1) TOTAL VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO- OOPHORECTOMY SECONDARY TO UTERINE PROLAPSE; (2) POSTERIOR REPAIR (RECTOCELE); (3) SLING URETHROPEXY; AND (4) ANTERIOR REPAIR (CYSTOCELE). DR (B)(6) PERFORMED THE TOTAL VAGINAL HYSTERECTOMY AND THE POSTERIOR REPAIR. DR (B)(6) PERFORMED THE SLING PROCEDURE AND THE CYSTOCELE REPAIR. THE PATIENT HAD DIFFICULTY URINATING POST OPERATIVELY AND WAS DISCHARGED TO HOME WITH A URINARY CATHETER. AT ONE-WEEK POST OP , THE CATHETER WAS REMOVED, BUT THE PATIENT WAS STILL UNABLE TO VOID. THE CATHETER WAS REINSERTED AND REMAINED IN PLACE FOR APPROXIMATELY THREE (3) WEEKS. THE PATIENT REPORTS THAT THE STRESS URINARY INCONTINENCE RETURNED ALMOST IMMEDIATELY ONCE THE CATHETER WAS REMOVED. THE PATIENT REPORTED THE INCONTINENCE TO DR (B)(6), BUT SHE DID NOT GO BACK TO DR (B)(6). SHE HAS NOT SEEN ANOTHER UROLOGIST ABOUT THE INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398493 BIODESIGN URETHRAL SLING SURGISIS URETHRAL SLING FTM COOK BIOTECH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability