BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 2051940 · Received March 14, 2011

    Report

    Report Number
    2210968-2011-00255
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DELAMINATION. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION: D4, H4 - THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBER: BATCH CKG490 MFG DATE: 02/29/2010, EXP DATE: 08/31/2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND MESH WAS USED. DURING THE PROCEDURE, THE MESH LAYERS STARTED TO DELAMINATE. THE SURGEON HAD GOOD OMENTAL COVERAGE, SO THIS PIECE OF MESH WAS STILL USED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK