BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM

    MDR report key: 1233652 · Received November 14, 2008

    Report

    Report Number
    2210968-2008-01119
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFECTION OCCURRED. 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 PATIENT DEVELOPED AN INFECTION AT AN UNSPECIFIED TIME FOLLOWING A HERNIA REPAIR WITH MESH IMPLANT. THE PATIENT WAS PRESCRIBED VANCOMYCIN AND CIPROFLOXIN. THE PHYSICIAN/SURGERY ROOM COORDINATOR OPINES THE INFECTION IS RELATED TO TECHNIQUE RATHER THAN THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED; NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE HERNIA SYSTEM PROLENE MESH HERNIA SYSTEM FTL ETHICON, INC. NA 15947-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention