BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BCS POLY

    MDR report key: 2820811 · Received November 6, 2012

    Report

    Report Number
    1020279-2012-00599
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    December 17, 2011
    Report Date
    October 30, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION WAS PERFORMED DUE TO POLY EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BCS POLY JOURN ART INS BCS STD 1-2 RT25 JWH SMITH & NEPHEW, INC. 06BM01158

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention