BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 2103116 · Received May 25, 2011

    Report

    Report Number
    2210968-2011-00672
    Event Type
    Injury
    Date Received
    May 25, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ETHICON
    Product Code
    FTL
    PMA / PMN Number
    K061533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECURRENT HERNIA. 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 A PATIENT UNDERWENT A HERNIA REPAIR ON AN UNKNOWN DATE AND MESH WAS USED. THE PATIENT EXPERIENCED A RECURRENT HERNIA ONE TO TWO YEARS AFTER THE INITIAL PROCEDURE. A SECOND SURGERY WAS SCHEDULED TO REPAIR THE HERNIA, HOWEVER, IT WAS CANCELLED WHEN PREOPERATIVE BLOOD WORK REVEALED THE PATIENT WAS PREGNANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC FTL ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention