BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIOMESH OVAL

    MDR report key: 4173408 · Received October 15, 2014

    Report

    Report Number
    2210968-2014-14576
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 26, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K093932
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON (B)(6) 2013 AND MESH WAS IMPLANTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED HERNIA RECURRENCE. THE PATIENT UNDERWENT A RE-OPERATION AND IT WAS DISCOVERED THAT MESH EDGE HAD COME LOOSE AND WAS ABLE TO BE PULLED OFF. ANOTHER MESH WAS IMPLANTED TO COMPLETE THE HERNIA REPAIR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653806 PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention