BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3182406 · Received June 21, 2013

    Report

    Report Number
    2210968-2013-10750
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2009 AND A MESH WAS IMPLANTED. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF PERIGEE PLACEMENT AND REMOVAL OF PREVIOUSLY IMPLANTED MESH AT THE VAGINAL APEX WITH CLOSURE OF THE VAGINAL MUCOSA DUE TO MESH EXTRUSION, ABDOMINAL PAIN AND PELVIC PAIN DURING MESH IMPLANTATION ON (B)(6) 2009. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE AND DYSPAREUNIA. THE PATIENT UNDERWENT A PROCEDURE IN (B)(6) 2014, NO OTHER DETAILS GIVEN. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).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 PATIENT UNDERWENT TRANSVAGINAL REMOVAL OF ERODED APICAL MESH AND OF PREVIOUSLY PLACED SLING MESH ON (B)(6) 2014 DUE TO DYSPAREUNIA WITH ERODED VAGINAL WALL MESH.

    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) 2009 AND MESH AND BARD ¿ SOFT MESH, PERIGEE SYSTEM W INTEPRO LITE WERE IMPLANTED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282929 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 3323195

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PERIGEE