BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 3033314 · Received April 3, 2013

    Report

    Report Number
    2210968-2013-03404
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    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 AN UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND MESH WAS USED. ON (B)(6) 2013, A NEW OPERATION ON THE SAME PATIENT WAS NECESSARY BECAUSE PATIENT SHOWED A RECURRENT HERNIA. DURING THE NEW OPERATION, THE SURGEON FOUND A NEW HERNIA WHICH CONTAINED OMENTUM IN THE SUPERIOR PART OF MESH. THE MESH WAS REMOVED AND A DIRECT PLASTIC OF THE WALL WAS CARRIED OUT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137167 PHYSIOMESH MESH, SURGICAL FTL ETHICON, INC. NA ED8JXMA0

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention