BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1083304 · Received July 25, 2008

    Report

    Report Number
    2210968-2008-00603
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 07/25/2008. - DELAMINATION - RESULT: THE ACTUAL DEVICE WAS RETURNED FOR EVAL. THE MESH WAS EXAMINED BY STEREOMICROSCOPE AT 10-40X AND IDENTIFIED AS THE PROLENE SOFT MESH COMPONENT. THE MESH AND ORC FABRIC WERE APPROX 10CMX15CM EACH. THE SHAPE SUGGESTED THAT THE MESH WAS CUT IN HALF AND ONLY ONE HALF WAS RETURNED. IN THE EMPTY PACKAGING AND ON THE MESH WAS A FINE WHITE POWDER THAT WAS EXAMINED BY FTIR AND DETERMINED TO BE PDS BY THE FTIR SPECTRUM OBTAINED. THE ORC COMPONENT WAS A DARK YELLOW OR AMBER COLOR, WHICH WAS SIGNIFICANTLY DARKER THAN USUALLY OBSERVED. CONCLUSION - NO CONCLUSION CAN BE DRAWN. THE FINE PARTICLES OF PDS AND DEEPER COLOR OF THE ORC WERE CONSISTENT IN APPEARANCE WITH SIGNIFICANT DEGRADATION, WHICH STRONGLY SUGGESTS RE-STERILIZATION OF THE PRODUCT OR COMPROMISED PACKAGING. THE CONDITION OF THE UNIT WHEN INITIALLY OPENED COULD NOT BE DETERMINED AS THE OUTER PACKAGING WAS NOT RETURNED. A COMPLETE EXAMINATION WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTS THAT THE DEVICE WAS DELAMINATED UPON OPENING THE PACKAGE. NO ADVERSE PT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA ZAG030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK