BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH

    MDR report key: 2832328 · Received November 14, 2012

    Report

    Report Number
    2210968-2012-07305
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ETHICON, INC
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MESH EXPOSURE. INFECTION OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-07304. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR AND COMPLEX ABDOMINAL RECONSTRUCTION ON (B)(6) 2011 AND MESH WAS USED. A RESECTION WAS PERFORMED AND SHE HAD REPAIR OF HER ABDOMINAL WALL WITH COMPONENT SEPARATION, RETRORECTUS PLACEMENT OF MESH AS WELL AS ONLAY PLACEMENT. IN ORDER TO RECONSTRUCT NORMAL ABDOMINAL WALL ANATOMY, MESH WAS USED AS AN OVERLAY TO CONNECT THE ANTERIOR RECTUS SHEATH TOGETHER. THE PATIENT DEVELOPED WOUND HEALING PROBLEMS WITH PURULENT DRAINAGE FROM HER ABDOMEN. IN 2012, THE PATIENT WAS DIAGNOSED WITH AN INFECTED ABDOMINAL WOUND WITH INFECTED MESH. THE MESH WAS SEEN EXPOSED IN HER WOUND WHICH HAD A MARKED AMOUNT OF GROSS PURULENCE. ON (B)(6) 2012, THE MESH WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPRO MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention