BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET GUARD

    MDR report key: 23376610 · Received October 24, 2025

    Report

    Report Number
    8021545-2025-02855
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    September 23, 2025
    Report Date
    June 5, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244022683
    PMA / PMN Number
    K210544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNOMEDICAL HEREBY SUBMITS THIS SUPPLEMENTAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CORRECTIVE AND PREVENTIVE ACTION (CAPA)/FDA ACTION PLAN.THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS SUPPLEMENTAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED. MEDICAL DEVICE REPORT (MDR) RETRACTION: THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (8021545-2025-02855) WAS SUBMITTED ON 24-OCT-2025. HOWEVER, BASED ON THE INVESTIGATION DONE ON 22-JAN-2026 AND CLINICAL REVIEW DONE ON 06- FEB- 2026, IT WAS FOUND THAT THE SERIOUS INJURY WAS NOT RELATED TO INFUSION SET AND THERE IS NO ALLEGATION ON THE INFUSION SET. NOW, THIS CASE HAS BEEN DETERMINED TO BE NON-REPORTABLE. HENCE, THIS MDR IS BEING SUBMITTED TO RETRACT THE INITIAL MDR. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: GERMANY. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT FACED EVENT OF LOW BLOOD GLUCOSE (B)(6) 2025. THE PATIENT TRIED TO TREAT WITH GLUCAGON. THEREFORE, THE PATIENT WENT TO HOSPITAL WITH BLOOD GLUCOSE OF 52 MG/DL ON (B)(6) 2025. AT THE TIME OF THIS REPORT, THE PATIENT WAS NOT RELEASED FROM THE HOSPITAL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403181 INSET GUARD UNO EWIS BLUE 60/6 HCAP 10PK INT FPA UNOMEDICAL UM-D MMT-431A UNKNOWN 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H