BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDITEC

    MDR report key: 19227588 · Received May 2, 2024

    Report

    Report Number
    3003207908-2024-00001
    Event Type
    Malfunction
    Date Received
    May 2, 2024
    Date of Event
    January 10, 2024
    Report Date
    April 30, 2024
    Manufacturer
    GCE, S.R.O.
    Product Code
    CAN
    UDI-DI
    08592346818088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS COMPLETELY CORRECT MARKING ON THE MEDICAL DEVICE. THE BOX LABEL INCLUDES THE WRONG FINAL PRODUCT NUMBER (REF). THE WHOLE DELIVERY WAS ISOLATED AND RELABELLED BY CORRECT BOX LABEL BEFORE RELEASE TO THE FOLLOWING DISTRIBUTION.

    Description of Event or Problem · 0

    THE BOX LABEL HAS THE WRONG FINAL PRODUCT NUMBER (REF). THERE WAS COMPLETELY CORRECT MARKING ON THE MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811590 MEDITEC MEDITEC CAN GCE, S.R.O. 0721109US 0000226073 08592346818088

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown