BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER MESH

    MDR report key: 1033805 · Received April 24, 2008

    Report

    Report Number
    2210968-2008-00276
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    December 1, 2007
    Report Date
    April 1, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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 STERILIZATION AND 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

    CUSTOMER REPORTED THAT A PATIENT HAD AN INCISIONAL HERNIA REPAIR IN 2007. THE PATIENT REPORTEDLY PRESENTED TO ANOTHER HOSPITAL ON APPROX SIX MONTHS LATER WITH FEVER. CT SCAN REVEALED AN INFECTION. PATIENT WAS PRESCRIBED ANTIBIOTICS. ON THE SAME DAY, PATIENT REPORTS SKIN OPENED UP WITH FLUID LOSS FROM WOUND. PATIENT RETURNED TO THE HOSPITAL WHERE SHE WAS ADMITTED AND WAS TAKEN TO SURGERY FOR REPAIR OF THE INFECTION ON TWO DAYS LATER. THE MESH WAS REMOVED, AND PATIENT PLACED ON A WOUND VAC FOR FURTHER HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERSILENE POLYESTER FIBER MESH MESH, SURGICAL FTL ETHICON, INC. NA XLE720

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention