BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL (POLYGLACTIN 910) MESH

    MDR report key: 2252104 · Received September 16, 2011

    Report

    Report Number
    2210968-2011-01313
    Event Type
    Injury
    Date Received
    September 16, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K810428
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    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 INGUINAL HERNIA REPAIR ON (B)(6) 2003 AND MESH WAS USED. THE PATIENT REPORTED THAT HE DEVELOPED PUS AT THE INCISION SITE APPROXIMATELY EIGHT MONTHS POST OPERATIVELY. THE PATIENT UNDERWENT A SECOND PROCEDURE ON AN UNKNOWN DATE AND PIECES OF THE MESH WERE REMOVED. THE PATIENT ALSO COMPLAINS OF NAUSEA AND DECREASED ENERGY AND REFUSES TO SEE THE SURGEON AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICRYL (POLYGLACTIN 910) MESH MESH, ABSORBABLE FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention