BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23614842 · Received November 21, 2025

    Report

    Report Number
    3003442380-2025-16895
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    November 9, 2025
    Report Date
    November 29, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K991759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 6013434, IN QUESTION WAS MANUFACTURED AT THE: REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 24-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6013434". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013434 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82AND MANUFACTURED IN THE MULTIVAC 12 ON 19-MAY-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. THE SUB-ASSEMBLY: THE LOT 5E03164 WAS ASSEMBLED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED ON 18-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E03485 WAS ASSEMBLED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED ON 19-MAY-2025, WITH A TOTAL OF (B)(4) UNITS THE LOT 5E03486 WAS ASSEMBLED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED ON 19-MAY-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. GLUING OF TUBING OF THE LOT 5E01603 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04, MP08, ON 17-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 5E01608 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04, MP08, ON 18-MAY-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: IN ORDER TO TEST THE PRODUCT, NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED, THEREFORE, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TEST OF REFERENCE SAMPLES., NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO 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.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: CHILE.

    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 CHILE. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO HIGH BLOOD GLUCOSE EVENT AND DIABETIC KETOACIDOSIS. THE BLOOD GLUCOSE LEVELS WAS 350 MG/DL AT THE TIME OF EVENT AND PATIENT GOT TREATED WITH INTRAVENOUS INSULIN. THE PATIENT STAYED IN THE HOSPITAL FOR LESS THAN TWENTY-FOUR HOURS. PATIENT EXPERIENCED SYMPTOMS LIKE VOMITING. PATIENT HAD KETONES WITH VALUE 3.5. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161655 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6013434 05705244017450

    Patients

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