BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 1971825 · Received January 11, 2011

    Report

    Report Number
    2210968-2011-00045
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    October 26, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - HEMATOMA OCCURRED. EVAL, CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6)2010 AND MESH WAS PLACED. POST OPERATIVELY, THE PT REPORTS THAT "A MASSIVE HEMATOMA DEVELOPED WHICH GREW BIGGER. THE WHOLE ABDOMEN WAS FULL OF BLOOD WITH PAIN AND ABDOMINAL DISTENSION. FELT LIKE RIPPING. THE AREA WAS SWOLLEN, BRUISED, INDURATED, VERY PAINFUL." THE PT REPORTS THEY WERE UNABLE TO GET IN OR OUT OF BED WITHOUT ASSISTANCE. FIVE WEEKS AFTER SURGERY, THE AREA CONTINUES TO BE SWOLLEN, DISTENDED, TENDER, PAINFUL, INDURATED, WITH SHARP STABS OF PAIN. THE PT HAS SEEN SEVERAL DIFFERENT DOCTORS AND THE PLAN IS TO OBSERVE. CURRENTLY, THE AREA IS NOT PURPLE ANYMORE, BUT THE PATIENT STILL HAS PAIN AND DISTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA CD8GQRZ0

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention