BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 3112276 · Received May 14, 2013

    Report

    Report Number
    2210968-2013-05529
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    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 THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012 AND MESH WAS USED. THE PATIENT DEVELOPED A RECURRENCE IN (B)(6) 2012 AND HAD A RE-OPERATION ON (B)(6) 2012. DURING THE RE-OPERATION, THE SURGEON NOTED THAT THE MESH HAD PULLED AWAY FROM THE LEFT SIDE AND THE MESH WAS REMOVED. CURRENTLY, THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211983 PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention