BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM MESH

    MDR report key: 3234113 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13714
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 3, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH REVISION OF VAGINAL CUFF INCISION AND EXCISION OF GRANULATION TISSUE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND A MESH WAS IMPLANTED CONCURRENTLY WITH TAH. IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXCISION ON (B)(6) 2011 DUE TO EROSION. IT WAS REPORTED THAT PATIENT UNDERWENT POSTERIOR REPAIR WITH XENFORM GRAFT PLACEMENT AND VAGINAL CUFF REVISION ON (B)(6) 2012 DUE TO VAGINAL DISCHARGE AND ODOR DUE TO EROSION AND URINARY PROBLEMS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 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
    336399 PROLENE HERNIA SYSTEM MESH MESH, SURGICAL, SYNTHETIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention