BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIALS

    MDR report key: 2875263 · Received December 17, 2012

    Report

    Report Number
    1020279-2012-00680
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALFUNCTION OF THE PRODUCT OCCURED WHICH EXTENDED SURGERY TIME OVER THIRTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIALS LGN OFFSET COUPLER TRIAL 6MM JWH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention 71434067