BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA PLUG

    MDR report key: 2992335 · Received March 7, 2013

    Report

    Report Number
    2210968-2013-02102
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 15, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    FTL
    PMA / PMN Number
    K070224
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2210968-2013-02101. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT A RIGHT INGUINAL HERNIA AND UMBILICAL HERNIA REPAIR ON (B)(6) 2010 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT HE EXPERIENCED COMPLICATIONS AND HE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES, INCLUDING SURGERY ON (B)(6) 2012, DUE TO MESH RIPPING. DURING THE SURGERY, IT WAS NOTED THAT THE MESH WAS INTACT INFERIORLY, BUT APPEARED TO HAVE RIPPED AND PULLED APART SUPERIORLY. A DIFFERENT MESH WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96745 ULTRAPRO HERNIA PLUG MESH, SURGICAL FTL ETHICON, INC NA BJ8JSJA0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention