BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FIX

    MDR report key: 3964288 · Received July 29, 2014

    Report

    Report Number
    1020279-2014-00464
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 25, 2014
    Report Date
    March 13, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442409 OPTI-FIX LINER JDH SMITH & NEPHEW, INC. 09LM04542

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization 427560/3B38501| 129935/T05554023| 71333580/12HM03937