BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2942389 · Received February 4, 2013

    Report

    Report Number
    2210968-2013-00704
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATES THIS EVENT DOES NOT MEET SERIOUS INJURY REPORTABILITY CRITERIA. THIS EVENT IS THEREFORE NOT REPORTABLE.

    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 A PATIENT UNDERWENT A SURGICAL PROCEDURE FOR A VENTRAL HERNIA REPAIR AND MESH WAS IMPLANTED INTO THE PATIENT. DURING A RE-EXPLORATORY SURGERY, THE SURGEON FOUND ADHESIONS TO THE MESH AND LACK OF INTEGRATION INTO THE FASCIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47058 PHYSIOMESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention