BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23540323 · Received November 13, 2025

    Report

    Report Number
    3003442380-2025-16360
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 13, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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: ARGENTINA. 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 6010403, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 12-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6010403". THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010403 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MACHINE 12 ON 23-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY LOT 4L01886 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ON 22-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY LOT 4L01887 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ON 23-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY LOT 4L01880 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ON 23--NOV-2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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 WAS PROVIDED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 1 SAMPLE OUT 10 SAMPLES WERE FOUND WITH A DEFECTIVE TUBING CONNECTOR THE CLICK LEG WAS CLOSED, NO RELATION WITH MALFUNCTION CODE. WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE NO MALFUNCTION BASED ON COMPLAINT INFORMATION. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: 1 SET WAS FOUND THE CONNECTOR THE CLICK LEG WAS CLOSED, NO RELATION WITH MALFUNCTION CODE, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, TWO COMPLAINS THRESHOLD 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 ARGENTINA. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE LEVEL WAS 573 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INSULIN INJECTION. THE PATIENT ALSO HAD SYMPTOMS LIKE VOMITING AND STOMACH DURING THE EVENT. THE LENGTH OF HOSPITALIZATION WAS FOR 1 WEEK. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165232 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6010403 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R