BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3242363 · Received July 23, 2013

    Report

    Report Number
    2210968-2013-14087
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 14, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2012 DUE TO PAIN, PERSISTENT SUI, AND SLING MIGRATION. ON (B)(6) 2012, PATIENT UNDERWENT ANOTHER GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED.

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A MESH WAS IMPLANTED CONCURRENTLY WITH LAPAROSCOPIC RIGHT SALPINGECTOMY AND LEEP OF CERVIX DUE TO RIGHT ADNEXAL MASS, SUI AND CIN-1 OF THE CERVIX. IT WAS REPORTED THAT PATIENT UNDERWENT LAPAROSCOPY, EXTENSIVE LYSIS OF ADHESIONS, PARTIAL LEFT SALPINGECTOMY, REVISION OF PRIOR SLING, PLACEMENT OF NEW MONARC SLING UTHROPEXY AND CYSTOSCOPY ON (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, 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) 2010 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND 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
    342520 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3413101

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention