BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3160770 · Received June 10, 2013

    Report

    Report Number
    2210968-2013-06924
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO UTEROVAGINAL WALL PROLAPSED AND STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF MESH AND VAGINAL GRAFT ON (B)(6) 2010 DUE TO URINARY INCONTINENCE/URGE AND DYSPAREUNIA.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH POSTERIOR COLPORRHAPHY AND VAGINAL COLPOPEXY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY AND VAGINAL TIGHTNESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED INTO THE PATIENT. IT WAS ALSO REPORTED THAT BARD-AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM WAS CONCURRENTLY IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH POSTERIOR COLPORRHAPHY AND VAGINAL COLPOPEXY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY AND VAGINAL TIGHTNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260605 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3080371

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention