BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2032710 · Received March 17, 2011

    Report

    Report Number
    2210968-2011-00284
    Event Type
    Injury
    Date Received
    March 17, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (HERNIA RECURRED). CONCLUSION: 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 A PT UNDERWENT A LAPAROSCOPIC VENTRAL HERNIA REPAIR IN (B)(6) 2010 AND MESH WAS USED. THERE WAS A RECURRENCE OF THE HERNIA DEFECT THAT WAS CONFIRMED SYMPTOMATICALLY AND CLINICALLY CONFIRMED BY CAT SCAN. ON (B)(6) 2011, THE PT HAD A SECOND SURGERY TO REPAIR THE DEFECT AND THE SURGEON NOTED THAT THERE WERE SEVERAL ADHESIONS AND THE MESH WAS NOT WELL INCORPORATED INTO THE ABDOMINAL WALL. THE PHYSICIAN REMOVED 90% OF THE ORIGINAL MESH AND REPAIRED THE HERNIA WITH ANOTHER MESH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIOMESH MESH, SURGICAL FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention