BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED VENTRAL PATCH

    MDR report key: 1945596 · Received December 27, 2010

    Report

    Report Number
    2210968-2010-01748
    Event Type
    Injury
    Date Received
    December 27, 2010
    Report Date
    December 3, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061533
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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 PT UNDERWENT A HERNIA REPAIR PROCEDURE IN (B)(6) 2010 AND MESH WAS PLACED. THE MESH "FAILED" AND WAS REMOVED ONE MONTH LATER IN (B)(6) 2010. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA CG8JHGZ0

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention