BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 180877 · Received August 4, 1998

    Report

    Report Number
    1045834-1998-00002
    Event Type
    Other
    Date Received
    August 4, 1998
    Report Date
    March 13, 1998
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO PACKAGES WERE REC'D BY THE DIST, LABELED AS GREY-MIA20-3 BURRS. INSTEAD THEY CONTAINED GREY-M1A16-3 BURRS. TWO SEPARATE PACKAGE WERE REC'D BY THE DIST, LABELED AS GREY-MIA16-3 BURRS. INSTEAD THEY CONTAINED GREY -MIA20-3 BURRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FLUTED BALL CUTTER HTT THE ANSPACH EFFORT, INC. NA RD0312 / RD0309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other