BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO HERNIA SYSTEM

    MDR report key: 1251743 · Received December 3, 2008

    Report

    Report Number
    2210968-2008-01207
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: A REVIEW OF THE BATCH MANUFACTURING 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 ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PATENT UNDERWENT A HERNIA REPAIR WITH MESH IMPLANT. THE PATIENT DEVELOPED WHAT WAS REPORTED AS A BUBBLE SENSATION UNDER THE SKIN AND WAS READMITTED FOR CAT SCAN. THE SCAN REVEALED FLUID AROUND THE REPAIR SITE THAT WAS LATER DIAGNOSED AS PUS. THE PATIENT WAS RETURNED TO SURGERY AND THE MESH EXPLANTED. THE WOUND SITE WAS CLEANSED AND THE PATIENT PLACED ON ANTIBIOTIC THERAPY. THE PATIENT IS REPORTED AS "DOING OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPRO HERNIA SYSTEM MESH, SURGICAL FTL ETHICON, INC. NA AH8DDMA0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention