BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH

    MDR report key: 3944976 · Received July 18, 2014

    Report

    Report Number
    2210968-2014-09629
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 23, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K851086
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH WAS IMPLANTED CONCURRENTLY WITH BLADDER SUSPENSION; BREAST RECONSTRUCTION WITH RIGHT UNILATERAL TRANS RECTUS ABDOMINIS MYOCUTANEOUS FLAP, AND CLOSURE OF ABDOMINAL DEFECT FROM TRAM FLAP ON MESH REINFORCEMENT OF ABDOMINAL DEFECT DUE TO SUI, POP, A HISTORY OF METASTATIC BREAST CANCER AND ACQUIRED DEFORMITY OF THE RIGHT CHEST AFTER BREAST CANCER. NO ADDITIONAL INFORMATION WAS PROVIDED. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, INFECTION, URINARY, DYSPAREUNIA AND SHE 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
    421389 MERSILENE POLYESTER FIBER MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. ZAE147

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR