BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 1790017 · Received August 2, 2010

    Report

    Report Number
    2210968-2010-00878
    Event Type
    Injury
    Date Received
    August 2, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - LIPOMA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT OPEN REPAIR OF AN UMBILICAL HERNIA ON (B)(6) 2009 BY INTRAPERITONEAL PLACEMENT OF A MESH. POST-OPERATIVELY, THE PT REPORTED DISABLING SYMPTOMS OF SENSATION OF MESH, PAIN AND MOVEMENT LIMITATIONS WHILE EXERCISING APPROX 1 YEAR AFTER PLACEMENT. ALSO, THE PT COMPLAINED OF PAIN ABOVE THE UMBILICUS. THE PT UNDERWENT A DIAGNOSTIC LAPAROSCOPY ON (B)(6) 2010. THE MESH WAS REPORTED BE WELL FLATTENED OUT AND NO RECURRENT HERNIA WAS IDENTIFIED. THE SURGEON REPORTS THE PRESENCE OF A LIPOMA BETWEEN THE MESH AND THE SKIN. THE LIPOMA WAS EXCISED. THE EVENT WAS RESOLVED ON (B)(6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention