BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH

    MDR report key: 1060638 · Received June 13, 2008

    Report

    Report Number
    2210968-2008-00441
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 16, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    INTL CUSTOMER REPORTED THAT A PT PRESENTED WITH A RECURRENT HERNIA APPROX ONE MONTH FOLLOWING AN INITIAL HERNIA REPAIR. THE HERNIA REPAIR WAS PERFORMED IN A LAPAROSCOPIC PROCEDURE USING PROLENE SUTURE TO ANCHOR THE MESH. THE PT REQUIRES SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPRO MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA ZJ8DSGR1

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention