BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH

    MDR report key: 3250376 · Received July 26, 2013

    Report

    Report Number
    2210968-2013-14737
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    June 29, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND A MESH WAS IMPLANTED, CONCURRENTLY WITH A HYSTERECTOMY, LSO, POSTERIOR REPAIR, SACRAL COLPOPEXY, BURCH URETHROPEXY, LYSIS OF ADHESIONS, CYSTOSCOPY, PARAVAGINAL DEFECT REPAIR, DUE TO POP, AND SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION/REMOVAL ON (B)(6) 2008 DUE TO SUI.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURES ON (B)(6) 2008 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS ALSO 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
    350976 MERSILENE POLYESTER FIBER MESH MESH, SURGICAL, SYNTHETIC FTL ETHICON INC. UNK QAE122

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention