BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL (POLYGLACTIN 910) MESH

    MDR report key: 1250123 · Received November 20, 2008

    Report

    Report Number
    2210968-2008-01153
    Event Type
    Injury
    Date Received
    November 20, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    k810428
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICRYL (POLYGLACTIN 910) MESH MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA ZP2037

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention