BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2820103 · Received November 6, 2012

    Report

    Report Number
    2210968-2012-07038
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND MESH WAS USED. SEVERAL MONTHS LATER, ON (B)(6) 2012, THE PATIENT UNDERWENT AN UNRELATED SURGICAL PROCEDURE. DURING THIS PROCEDURE, THE SURGEON MADE AN INCISION THROUGH THE MID LINE AND OBSERVED THE INITIAL MESH DID NOT HAVE ANY TISSUE INCORPORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention