BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET GUARD

    MDR report key: 23483330 · Received November 5, 2025

    Report

    Report Number
    8021545-2025-03033
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 12, 2025
    Report Date
    November 4, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018877
    PMA / PMN Number
    K173879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 6013610. IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 04-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH","LOT NUMBER" CRITERIA EQUAL #6013610. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6013610 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) [80] APPENDIX 1 BATCHCARD FOR PRODUCTION OF PACKAGING ROOM ON 11-JUN-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 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 2429472 THE BATCH 6013610. IN QUESTION WAS MANUFACTURED AT THE OSTED SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON (B)(6) 2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH" ,"LOT NUMBER" CRITERIA EQUAL #6013046. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6013610 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) [APPENDIX 1 BATCHCARD FOR PRODUCTION OF PACKAGING ROOM ON (B)(6) 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.

    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 WENT TO THE EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYPOGLYCEMIA. THE BLOOD GLUCOSE LEVEL WAS 27 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH TORTILLA AND HONEY 2 PCS GLUCOSE SHOT AND GLUCAGON. THE LENGTH OF ER STAY IS FOR LESS THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264712 INSET GUARD UNO MIO ADV. GREY 60/6 SC1 10-PK INT FPA UNOMEDICAL A/S MMT-242A 6013610 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention