BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM ARTHROGRAM TRAY

    MDR report key: 21515 · Received April 27, 1995

    Report

    Report Number
    MW1005757
    Event Type
    Injury
    Date Received
    April 27, 1995
    Date of Event
    March 13, 1995
    Report Date
    April 4, 1995
    Manufacturer
    NI-MED, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "NOT REPORTABLE" UNDER THE GUIDELINES OF REGULATION 21, CFR SECTION 803.

    Description of Event or Problem · 1

    POSTMARK DATE: 5/23/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM ARTHROGRAM TRAY CUSTOM ARTHROGRAM TRAY KDD NI-MED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention