BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET GUARD

    MDR report key: 23252140 · Received October 9, 2025

    Report

    Report Number
    8021545-2025-02725
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    September 7, 2025
    Report Date
    October 31, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K210544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (8021545-2025-02725), WAS SUBMITTED ON 09-OCT-2025. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 14-APR-2025. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY - COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6012603. IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 31-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH","LOT NUMBER" CRITERIA EQUAL 6012603. THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6012603 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) [80] APPENDIX 1 BATCHCARD FOR PRODUCTION OF PACKAGING ROOM ON 14-APR-2025 WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY (B)(6), PATIENT COUNTRY - UNITED STATES.

    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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED IN HOSPITAL ON (B)(6) 2025 DUE TO DIABETIC KETOACIDOSIS. PATIENT EXPERIENCED SYMPTOMS LIKE HEADACHE, SICK/UNWELL, TIRED/WEAK, EXTREMITY PAIN/CRAMPS. THE BLOOD GLUCOSE LEVEL WAS 600 MG/DL AT THE TIME OF EVENT AND PATIENT WAS TREATED WITH INTRAVENOUS INSULIN DRIP. THE PATIENT STAYED IN THE HOSPITAL FOR MORE THAN TWENTY-FOUR HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348151 INSET GUARD EWIS BLUE 80/9 HCAP 5-PACK FPA UNOMEDICAL A/S MMT-442AG 6012603

    Patients

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