BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EWIS BLUE 60/6 HCAP 5-PACK

    MDR report key: 19597424 · Received June 24, 2024

    Report

    Report Number
    8021545-2024-01455
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 24, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1894827 - MDR 8021545-2024-01456 - DEVICE 2 OF 2. E1: (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSIONS SET TAP NOT STICKING EVENT ON (B)(6) 2024. IT CAME OFF DURING SHOWER. NON-SERIALIZED PRODUCT BEING REPLACED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762509 EWIS BLUE 60/6 HCAP 5-PACK EWIS BLUE 60/6 HCAP 5-PACK FPA UNOMEDICAL A/S MMT-431AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown