BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 2884073 · Received December 21, 2012

    Report

    Report Number
    2210968-2012-08428
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2008-00189. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIORRAPHY ON (B)(6) 2006 AND MESH WAS IMPLANTED. THE PATIENT HAS EXPERIENCED DIGESTIVE ISSUES AND UNDERWENT AN UPPER GASTOINTESTIONAL ENDOSCOPIC PROCEDURE ON (B)(6) 2010. THE PATIENT HAS BEEN TREATED FOR H. PYLORI AND IS CURRENTLY ON OMEPRAZOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA TME109

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention