BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESA LABORATORIES 7.0 PH BUFFER SOLUTION

    MDR report key: 3653234 · Received January 24, 2014

    Report

    Report Number
    3653234
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    October 4, 2013
    Report Date
    October 8, 2013
    Manufacturer
    MESA LABORATORIES
    Product Code
    JCC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REC'D NOTIFICATION OF POTENTIAL MOLD GROWTH IN THE IDENTIFIED LOT NUMBERS FROM (B)(4). AFFECTED LOT NUMBERS IDENTIFIED AND REMOVED FROM THE FACILITY STOCK. NO PT ADVERSE EVENTS HAVE OCCURRED AS A RESULT OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55792 MESA LABORATORIES 7.0 PH BUFFER SOLUTION NONE JCC MESA LABORATORIES ML-P7-1122
    55793 MESA LABORATORIES 7.0 PH BUFFER SOLUTION NONE JCC MESA LABORATORIES ML-P7-1122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other