BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3132508 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-05973
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 5, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 BY THE PATIENT THAT SHE UNDERWENT A HERNIATED INCISION REPAIR PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPALNTED. THE PATIENT IS NOW FACING HER SIXTH SURGERY FOR REMOVAL OF MESH. FOR THE PAST SEVEN YEARS, THE PATIENT HAS EXPERIENCED DIMINISHED ENJOYMENT IN HIKING, BIKING, SKIING, AND SWIMMING. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237464 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention