BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EWIS BLUE 60/6 HCAP 5-PACK

    MDR report key: 19858132 · Received July 29, 2024

    Report

    Report Number
    8021545-2024-02766
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    June 21, 2024
    Report Date
    July 29, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1925870 - DEVICE 1 OF 5. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED FIVE ADHESIVE EVENT AS THE TAPE WAS NOT STICKING AND INFUSION SET FELL OFF DURING USE ON (B)(6) 2024. PATIENT WASTED 5 INFUSION SETS IN LESS THAN A WEEK. PATIENT CONFIRMED TO BE TOTALLY OUT OF EXTENDED INFUSION SET. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199527 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