BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1222121 · Received November 5, 2008

    Report

    Report Number
    2210968-2008-01096
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K031925
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    INTL CUSTOMER REPORTED THAT A PT UNDERWENT AN OPEN LAPAROSCOPIC HERNIA REPAIR IN 2007 WITH MESH IMPLANT. THE PT IS CURRENTLY HOSPITALIZED AND UNDERGOING TREATMENT FOR A FISTULA. ADD'L INFO WAS REQUESTED; NO FURTHER INFO HAS BEEN RECEIVED.

    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 Required Intervention