BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTAMIX BAG

    MDR report key: 4764489 · Received May 6, 2015

    Report

    Report Number
    MW5042591
    Event Type
    Malfunction
    Date Received
    May 6, 2015
    Date of Event
    April 9, 2015
    Report Date
    May 6, 2015
    Manufacturer
    BAXA
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    EXACTAMIX 3000 ML BAG, LOT # 1021535, EXP DATE: 11/2017 WAS FOUND TO HAVE A TEAR DURING COMPOUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296791 EXACTAMIX BAG EXACTAMIX BAG, 3000 ML LHI BAXA * 1021535

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR