BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C TAPER COCR LFIT HEAD

    MDR report key: 298560 · Received September 26, 2000

    Report

    Report Number
    2243265-2000-00078
    Event Type
    Malfunction
    Date Received
    September 26, 2000
    Date of Event
    August 30, 2000
    Report Date
    September 26, 2000
    Manufacturer
    HOWMEDICA OSTEONICS
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUTER PACKAGING STATED PRODUCT TO BE AN 06-2600 C-TAPER HEAD. WHEN PACKAGE WAS OPENED OPERATING ROOM STAFF FOUND THAT PACKAGE CONTAINED AN 06-2610 C-TAPER HEAD. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C TAPER COCR LFIT HEAD IMPLANT KWY HOWMEDICA OSTEONICS NA 56629202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other