BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2933387 · Received January 29, 2013

    Report

    Report Number
    2210968-2013-00622
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    December 28, 2012
    Manufacturer
    ETHICON, IN.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND MESH WAS IMPLANTED. ON (B)(6) 2012, THE PATIENT UNDERWENT A GASTRIC BYPASS PROCEDURE. DURING THIS PROCEDURE THE SURGEON NOTED SERIOUS ADHESIONS WITH MASSIVE INTERGROWTH TO THE OMENTUM. THE SURGEON NEEDED TO PERFORM TOTAL ADHESIOLYSIS CAUSING ADDITIONAL TIME TO THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38934 PHYSIOMESH MESH, SURGICAL, POLYMERIC FTL ETHICON, IN. NA DC8BXWA1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention