BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23580046 · Received November 18, 2025

    Report

    Report Number
    3003442380-2025-16659
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 27, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K160648
    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 (3003442380-2025-16659), WAS SUBMITTED ON 18-NOV-2025. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 19-JAN-2024. 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 6012428, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 26-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6012428". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. TEST RESULTS: NO SAMPLE WAS PROVIDED, AS IN METIONED IN THE REPORT. "SHIP: NOTHING / RETURN: NOTHING". VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WORK INSTRUCTION (WI) VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL LEAK TEST 2 ACCORDING TO WORK INSTRUCTION (WI) VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKAGING: THE LOT 6012428 WAS PACKAGING ACCORDING TO THE[?]WI 4902100 VERSION 82, IN THE MULTIVAC M12, ON 19/JAN/2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY OF QUICKSET THE LOT 5C03018 WAS ASSEMBLED ACCORDING TO WORK INSTRUCTION (WI) VERSION 29 IN THE ASSEMBLY OF QUICKSET ON 15 JAN 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C03019 WAS ASSEMBLED ACCORDING TO WORK INSTRUCTION (WI) VERSION 29 IN THE ASSEMBLY OF QUICKSET ON 26 MAR 2024, WITH A TOTAL OF (B)(4) UNITS GLUING TUBE THE LOT 5C03030 WAS ASSEMBLED ACCORDING TO WORK INSTRUCTION (WI) VERSION 42 IN THE GLUING TUBE OF QUICKSET ON 23 MAR 2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5C03031 WAS ASSEMBLED ACCORDING TO WORK INSTRUCTION (WI) VERSION 42 IN THE GLUING TUBE OF QUICKSET ON 24 MAR 2024, 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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION UNRELATED 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

    PATIENT CITY: (B)(6) PATIENT COUNTRY: CANADA.

    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 CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT ON (B)(6) 2025. THE PATIENT FIRST WENT TO EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED. THE PATIENT WAS INITIALLY TREATED WITH GLUCOSE TABLETS. DURING HOSPITALIZATION THE PATIENT WAS TREATED WITH INSULIN DELIVERY THROUGH PUMP. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494497 QUICK SET UNO QUICK-SET 60/9 SC1 MCAN FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A600 6012428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention