BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT SECUR SYSTEM

    MDR report key: 3212295 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12506
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    July 7, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXCISION, GRANULATION TISSUE EXCISION, COLPOCLEISIS, AND POSTERIOR COLPOPERINEORRHAPHY ON (B)(6) 2013 DUE TO POP, UNDESIRED SEXUAL FUNCTION, PERSISTENT APICAL GRANULATION TISSUE IN THE VAGINA AND PELVIC PAIN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH ANTERIOR & POSTERIOR COLPORRHAPHY, SACROSPINOUS LIGAMENT FIXATION WITH ELEVATION OF THE VAGINAL VAULT DUE TO SUI, SYMPTOMATIC CYSTOCELE & RECTOCELE, VAGINAL VAULT PROLAPSED AND HYPERMOBILE URETHRA.

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311895 GYNECARE TVT SECUR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC PAH ETHICON INC. UNK 3322096

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention