BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH

    MDR report key: 3140441 · Received May 31, 2013

    Report

    Report Number
    2210968-2013-06338
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2013 AND MESH WAS IMPLANTED. TWO WEEKS POST OPERATIVE, THE PATIENT COMPLAINED OF PAIN AND FEELING UNCOMFORTABLE. THE PATIENT DEVELOPED A DEHISCENCE. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2013. DURING THAT TIME IT WAS NOTED THAT THE MESH WAS "DESTROYED". THE MESH WAS REMOVED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242313 ULTRAPRO MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention