BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH OVAL

    MDR report key: 3821534 · Received May 20, 2014

    Report

    Report Number
    2210968-2014-06369
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - HERNIA RECURRED. 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 A LAPAROSCOPIC IPOM EPIGASTRIC HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013 WITH NO ISSUES. THE PATIENT REPORTED PROBLEMS IN (B)(6) 2013. THE PHYSICIAN CONFIRMED RECURRENCE CLINICALLY AND BY CT SCAN AND THE PATIENT UNDERWENT A RECURRENT HERNIA REPAIR PROCEDURE ON (B)(6) 2014. THE PATIENT UNDERWENT AN OPEN PROCEDURE TYPE RAMIREX ON (B)(6) 2014. CURRENTLY THE PATIENT IS DOING FINE AND IS DUE FOR A VISIT IN SOME WEEKS FROM NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299521 PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention