BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA SYSTEM

    MDR report key: 3102422 · Received May 9, 2013

    Report

    Report Number
    2210968-2013-05346
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 13, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    FTL
    PMA / PMN Number
    K071249
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    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 BILATERAL OPEN REPAIR OF INGUINAL HERNIAS ON (B)(6) 2009 AND MESH WAS IMPLANTED. ON (B)(6) 2009, THE PATIENT REPORTED PAIN WITH EXERCISE AND BENDING. THE PATIENT WAS TREATED WITH AN INJECTION AT THE SORE SPOT WITH DIPROPHOS AND MARCAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204244 ULTRAPRO HERNIA SYSTEM MESH, SURGICAL FTL ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention