BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH

    MDR report key: 3233738 · Received July 18, 2013

    Report

    Report Number
    2210968-2013-13665
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE BOSTON SCIENTIFIC ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS CONCURRENTLY IMPLANTED ON (B)(6) 2010. THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, FISTULAE, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. ON (B)(6) 2012, THE PATIENT UNDERWENT A VAGINAL CLOSURE, UTEROSACRAL VAULT SUSPENSION AND ENTEROCELE REPAIR SECONDARY TO VAGINAL AND BOWEL EROSION WITH 12¿ BOWEL EVISCERATION THROUGH THE VAGINA. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO CYSTOCELE.

    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) 2010 AND MESH WAS IMPLANTED CONCURRENTLY WITH SACROCOLPOPEXY PROCEDURE. THERE IS MENTION OF THE ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM BEING IMPLANTED, HOWEVER, THERE IS NO FURTHER CLARIFYING INFORMATION PROVIDED. 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
    334341 MERSILENE POLYESTER FIBER MESH MESH, SURGICAL FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BOSTON SCIENTIFIC ADVANTAGE SLING