BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM

    MDR report key: 2032687 · Received March 17, 2011

    Report

    Report Number
    2210968-2011-00283
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    March 11, 2008
    Report Date
    February 14, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - HYDROCELE; LOW TESTOSTERONE . (B)(4) - PRESSURE ON THE SPERMATIC CORD. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2008, AND MESH WAS USED. POST-OPERATIVELY, THE PT HAS HAD SEVERE PAIN. IN (B)(6) 2010, THE PT WAS DIAGNOSED WITH HYDROCELE AND LOW TESTOSTERONE. ON (B)(6) 2010, THE PT HAD SURGERY TO REMOVE PRESSURE ON THE SPERMATIC CORD AND TO CORRECT THE HYDROCELE. THE SURGEON REMOVED THE OUTER PART OF THE MESH AND RELEASED IT FROM THE SPERMATIC CORD. THE INNER MESH WAS LEFT IN PLACE. TESTOSTERONE REPLACEMENT THERAPY WAS STARTED AND THE PAIN HAS REDUCED. THE PT STILL HAS PAIN WITH EJACULATING AND BRUISING IN THE TESTICLES. AN APPOINTMENT WITH AN UROLOGIST IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE HERNIA SYSTEM MESH, SURGICAL FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention