BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MULTI-LAYER LAMINATE MESH

    MDR report key: 1212108 · Received October 24, 2008

    Report

    Report Number
    2210968-2008-01041
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 13, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 10/24/2008. INFECTION OCCURRED- CONCLUSION: 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 UNDERWENT A LAPAROSCOPIC UMBILICAL HERNIA REPAIR WITH MESH IMPLANT. THE PT DEVELOPED SIGNS OF SEPSIS AND AN ACUTE ABDOMEN BEGINNING ONE DAY POST SURGERY. A LAPAROSCOPY WAS PERFORMED WHICH SHOWED A NORMAL AND UNEVENTFUL ABDOMEN. THESE SYMPTOMS RESOLVED SPONTANEOUSLY THEN RECURRED TWO DAYS LATER. IT WAS DECIDED NOT TO INTERVENE. ANTIBIOTICS WERE PRESCRIBED. NO FURTHER INTERVENTION WAS PROVIDED; THE PT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCEED MULTI-LAYER LAMINATE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA ADG246

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention