BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSTAINER LINK 48 INSTRUMENT SYSTEM

    MDR report key: 10412423 · Received August 17, 2020

    Report

    Report Number
    2022180-2020-00215
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    July 22, 2020
    Report Date
    August 17, 2020
    Manufacturer
    DAKO NORTH AMERICA, INC
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BASED ON COMPLAINT REPORT OR INVESTIGATED FAILURE MODE, THERE WAS POTENTIAL FOR A STAINING ALTERATION. CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: WEAK OR POOR STAINING. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876325 AUTOSTAINER LINK 48 INSTRUMENT SYSTEM AUTOSTAINER LINK 48 INSTRUMENT SYSTEM KPA DAKO NORTH AMERICA, INC AS480

    Patients

    Seq Age Sex Outcome Treatment
    1