BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED* MULTI-LAYER LAMINATE MESH

    MDR report key: 3030546 · Received April 2, 2013

    Report

    Report Number
    2210968-2013-03273
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING 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 OPEN VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED SYMPTOMS OF AN INFECTION OR FOREIGN BODY REACTION WHILE STILL IN THE HOSPITAL AFTER PROCEDURE. THE MESH WAS REMOVED ON 03/08/2013. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134168 PROCEED* MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA EDG106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention