BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 3083171 · Received April 29, 2013

    Report

    Report Number
    2210968-2013-04670
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THE CONCERNED SAMPLE SHOWS AN INTACT MESH OF THE NON ABSORBABLE PART OF THE EXPLANTED DEVICE. THE APPEARANCE OF THE RING IS WHAT IS EXPECTED AFTER IMPLANTATION FOR MORE THAN THREE WEEKS AND THE LONG EXPOSURE PERIOD TO AIR. THE CAUSE FOR THE EVENT COULD NOT BE VERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4) - INFECTION OCCURRED. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. THE PATIENT DEVELOPED A STAPH A INFECTION. AN OPEN ABDOMINAL RE-OPERATION WAS DONE ON (B)(6) 2013. DURING THE PROCEDURE IT WAS NOTED THAT THE MESH WAS DISINTEGRATED AND THE RING WAS IN PIECES. THE MESH WAS REMOVED AND A VACUUM WAS PLACED OVER THE INFECTED AREA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. THE PATIENT DEVELOPED A STAPH A INFECTION. A REOPERATION WAS DONE ON (B)(6) 2013. DURING THE PROCEDURE IT WAS NOTED THAT THE MESH WAS DISINTEGRATED AND THE RING WAS IN PIECES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185429 PROCEED VENTRAL PATCH MESH SURGICAL POLYMERIC FTL ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention