BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH

    MDR report key: 4180030 · Received October 17, 2014

    Report

    Report Number
    2210968-2014-14665
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    June 28, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    PRE-AMEND
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED. ON (B)(6) 2008 THE PATIENT UNDERWENT A LAPAROSCOPIC, VAULT MESH SUSPENSION, UTEROSACRAL PLICATION AND OBLITERATION OR ENTEROCELE SPACE DUE TO VAGINAL PROLAPSE POST HYSTERECTOMY AND FAILED A&P REPAIR.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 06/30/2017 ADDITIONAL INFORMATION

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES. 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
    662444 MERSILENE POLYESTER FIBER MESH MESH, SURGICAL FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention