BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH

    MDR report key: 2103109 · Received May 25, 2011

    Report

    Report Number
    2210968-2011-00670
    Event Type
    Injury
    Date Received
    May 25, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ETHICON INC
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECURRENT HERNIA. 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.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2011. 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 LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2011 AND MESH WAS USED. THE MESH PULLED AWAY FROM THE ABDOMINAL WALL ON AN UNKNOWN DATE. THE PATIENT UNDERWENT A LAPAROSCOPIC AND OPEN LAPAROTOMY WITH REMOVAL OF THE MESH AND A REPAIR OF THE RECURRENT VENTRAL HERNIA USING A DIFFERENT MESH ON (B)(6) 2011. THE PATIENT WAS STABLE AFTER SURGERY AND DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIOMESH MESH, SURGICAL FTL ETHICON INC NA CH9CSZZ0

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention