BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 24966909 · Received April 23, 2026

    Report

    Report Number
    3003442380-2026-09625
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    January 26, 2026
    Report Date
    March 26, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A DE C.V
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER. REPORTING SITE: 8021545. MANUFACTURING SITE: 3003442380.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FACED INFECTION AT INFUSION SET INSERTION SITE EVENT ON (B)(6) 2026. PATIENT GETTING TREATMENT FOR WOUND CARE AT WOUND CARE CENTER. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600687 INSET SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL DEVICES S.A DE C.V 1001680 6014418 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female