BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972855 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01522
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2000 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED EROSION OF THE SUSPENSION TAPE INTO THE MID URETHRA. IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY, PLACEMENT OF SUPRAPUBIC TUBE ON (B)(6) 2000. IT WAS REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY, ISOLATION OF TVT, DISSECTION OF THE TAPE, BISECTION OF THE TAPE ON (B)(6) 2000. ON (B)(6) 2004 THE PATIENT UNDERWENT I&D OF AN ABDOMINAL WALL ABSCESS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2000 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING INABILITY TO ENGAGE IN ACTIVITIES, PAIN, DISABILITY AND SHE DIED ON (B)(6) 2008. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75560 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention