BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH

    MDR report key: 3884160 · Received June 19, 2014

    Report

    Report Number
    2210968-2014-07918
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    November 11, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K851086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2001 AND A MESH WAS IMPLANTED CONCURRENTLY WITH DEFECT-DIRECTED POSTERIOR REPAIR AND HALBAN CULDOPLASTY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, URINARY PROBLEMS, RECURRENCE AND BLEEDING. IT WAS REPORTED THAT PATIENT UNDERWENT PARTIAL REMOVAL ON (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2001 AND MESH WAS IMPLANTED CONCURRENTLY WITH SURGISIS. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361363 MERSILENE POLYESTER FIBER MESH MESH, SURGICAL FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention