BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 3983485 · Received August 6, 2014

    Report

    Report Number
    2210968-2014-10869
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    June 9, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2014 AND MESH WAS IMPLANTED. ON (B)(6) 2014, DRAINAGE FROM JP DRAIN WAS CULTURED AND WAS POSITIVE FOR STAPH AUREUS. THE PATIENT FOLLOWED UP WITH PHYSICIAN AND WAS TREATED WITH BACTRIM. ON (B)(6) 2014, THE PATIENT WAS SEEN IN EMERGENCY DEPARTMENT FOR REDNESS, PAIN TO AREA AND DRAINAGE. INCISION AND DRAINAGE WAS PERFORMED AND PATIENT WAS ADMITTED TO HOSPITAL. ON (B)(6) 2014, THE MESH WAS REMOVED AND CALLED ¿INFECTED¿. THE PATIENT HAS BEEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459666 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK GEB694

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention JP DRAIN