BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2021310 · Received March 7, 2011

    Report

    Report Number
    2210968-2011-00229
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 4, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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. 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 PT UNDERWENT A LAPAROSCOPIC RECURRENT UMBILICAL INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2011 AND MESH WAS USED. THE PT EXPERIENCED AN INTESTINAL COLON PERFORATION, NOT DETECTED AT TIME OF SURGERY DUE TO THERMAL INJURY. ON (B)(6) 2011, THE PT DEVELOPED PERITONITIS AND AN INFECTED HERNIA IN THE COLON AND OMENTUM. ANAEROBES AND YEAST WERE IDENTIFIED IN THE CULTURES. A RE-OPERATION WAS PERFORMED WITH A MIDLINE INCISION ON (B)(6) 2011. THE MESH HAD SEPARATED FROM THE ABSORBABLE TACKS, THE MESH WAS REMOVED AND THE SURGEON PERFORMED A PARTIAL COLON RESECTION WITH ANASTAMOSIS. THE HERNIA WAS REPAIRED WITH A DIFFERENT MESH. THE SURGEON OPINES THAT THE HERNIA BECAME INFECTED BECAUSE OF THE COLON PERFORATION. THE PT IS CURRENTLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIOMESH MESH, SURGICAL FTL ETHICON, INC. NA CJ9KPHZ1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention