BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM

    MDR report key: 3040112 · Received April 8, 2013

    Report

    Report Number
    2210968-2013-03551
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT INGUINAL HERNIA REPAIR SURGERY ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, AND ADDITIONAL UNSPECIFIED INJURIES, AND HE 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
    143918 PROLENE HERNIA SYSTEM PROLENE MESH HERNIA SYSTEM FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention