BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET 30

    MDR report key: 23601413 · Received November 20, 2025

    Report

    Report Number
    3003442380-2025-16810
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 22, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 6014079, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 21-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6014079. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR)REVIEW: THE LOT 6014079 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12 ON 28-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 5F05704 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED IN THE QUICKSET LINE, ON 28-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 5F05705 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED IN THE QUICKSET LINE, ON 29-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 5F05949 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED IN THE QUICKSET LINE, ON 30-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 5F02594 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE 04 -08, ON 26-JUN-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 5F05703 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE 08, ON 27-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 PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WI GUIDANCE FOR VISUAL TEST FOR COMPLAINTS AREA VERSION 3: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. WI GUIDANCE FOR FUNCTIONAL TESTING 1 AIR FLOW TEST FOR COMPLAINTS AREA VERSION 2: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. WI GUIDANCE FOR FUNCTIONAL TESTING 2 AIR LEAK TEST FOR COMPLAINTS AREA VERSION 2: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, 1 COMPLAINT IN THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, 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

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED LOW BLOOD GLUCOSE LEVELS ON (B)(6) 2025. THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE AND EXPERIENCED PASSED OUT EVENT AND HIT HER FACE, BROKE NOSE AND FOOT. THE PATIENT WAS TREATED BY GIVING SOMETHING TO EAT. THE PATIENT WAS IN THE HOSPITAL FOR LESS THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441910 INSET 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL A/S MMT-397A 6014079 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention