BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXINIUM

    MDR report key: 2870762 · Received December 12, 2012

    Report

    Report Number
    1020279-2012-00676
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    SMITH&NEPHEW, INC
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXINIUM OXINIUM FEM HD 12/14 28MM +0 JDH SMITH&NEPHEW, INC 03GM00970

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R (B)(4) -REF NO HOLE SHELL SZ 50MM (B)(4)| (B)(4) -REF LNR 28X50-52 20 DEG SZ E (B)(4)