BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH

    MDR report key: 1251744 · Received December 3, 2008

    Report

    Report Number
    2210968-2008-01205
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 26, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 12/03/2008. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE PATIENT UNDERWENT AN OPEN INCISIONAL/VENTRAL HERNIA REPAIR PROCEDURE IN 2008, DURING WHICH ULTRAPRO MESH WAS USED. POSTOPERATIVELY NINE DAYS LATER, IT WAS NOTED THAT THE PATIENT HAD DEVELOPED A SEROMA. THE SEROMA WAS EVACUATED AND SUBSEQUENTLY REPORTED AS RESOLVED THE FOLLOWING MONTH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention