BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLARUS BROACH

    MDR report key: 385597 · Received March 25, 2002

    Report

    Report Number
    3025141-2001-00005
    Event Type
    Other
    Date Received
    March 25, 2002
    Date of Event
    November 7, 2001
    Report Date
    March 23, 2002
    Manufacturer
    ACUMED, INC.
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE NOTICED THAT THE POLARUS BROACH WAS MIS-LABELED. THIS EVENT OCCURRED DURING AN INSERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARUS BROACH CANCELLOUS BONE REAMER HTO ACUMED, INC. HR-B115 W03397

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other