BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISION FLEX+, MOUSE, HIGH PH (LINK)

    MDR report key: 5773482 · Received July 6, 2016

    Report

    Report Number
    9610099-2016-00007
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    June 14, 2016
    Report Date
    July 6, 2016
    Manufacturer
    DAKO DENMARK A/S
    Product Code
    LDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BASED ON CUSTOMER COMPLAINTS, IT WAS DISCOVERED THAT THE PH OF THE TARGET RETRIEVAL SOLUTION MEASURED 4-5 INSTEAD OF THE CORRECT PH OF 9.1. THE CUSTOMER COMPLAINT WAS RELATED TO NO STAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427768 ENVISION FLEX+, MOUSE, HIGH PH (LINK) ENVISION FLEX+, MOUSE, HIGH PH (LINK) LDT DAKO DENMARK A/S K8002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other