BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA SYSTEM

    MDR report key: 3030629 · Received April 2, 2013

    Report

    Report Number
    2210968-2013-03279
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K071249
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    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. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT HE HAD DISCOMFORT WITH TWO LUMPS IN THE GROIN AREA. HE UNDERWENT A RECURRENT INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2011 AND MESH WAS USED. AFTER RECOVERING FROM EXCRUCIATING PAIN FROM THE SURGERY, CERTAIN PAINS NEVER WENT AWAY AND NEW PAINS BEGAN TO APPEAR IN THE GROIN AREA AND TESTICLES. AFTER A FEW SCRIPTS FOR PAIN, THE PATIENT WAS SENT TO PAIN MANAGEMENT FOR NERVE BLOCK INJECTIONS AND STRONG PAIN KILLERS. THE PATIENT IS ON 75MG OF MORPHINE EVERY DAY JUST TO MASK THE PAIN. INJECTIONS WOULD RELIEVE PAIN FOR A COUPLE DAYS AND THEN THE PAIN WOULD RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134274 ULTRAPRO HERNIA SYSTEM MESH, SURGICAL FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention