BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23653674 · Received November 26, 2025

    Report

    Report Number
    3003442380-2025-16825
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 25, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 6013436, 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 #6013436. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013436 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC M12 ON 23-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 5E03507 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED IN THE QUICKSET LINE, ON 23-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 5E03508 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED IN THE QUICKSET LINE, ON 23-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 5E03431 WAS MANUFACTURED ACCORDING TO THE[?]WI-4905078 VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE MP04 - MP08, ON 22-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE REVIEW OF THE DHR REVEALED THAT DURING OUTGOING TEST 9 (OTHERS), ONE SAMPLE WAS FOUND WITH A MISALIGNED PRINT ON THE BUN. CONSEQUENTLY, AN EXTENDED FOR THIS ISSUE WAS RAISED. HOWEVER, ACCORDING TO THE SAMPLING RESULTS, THE LOT WAS ACCEPTED. FURTHERMORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED IN RELATION TO THE 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. 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 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.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED ARAB EMIRATES.

    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 ARAB EMIRATES. IT WAS REPORTED THAT PATIENT VISITED EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCAEMIA ON THE FIRST DAY OF INSERTION. THE BLOOD GLUCOSE LEVEL AT THE TIME OF THE EVENT WAS 500 MG/DL. THE PATIENT WAS TREATED WITH INTRAVENOUS INSULIN. THE LENGTH OF HOSPITALIZATION WAS LESS THAN A DAY. THE PATIENT EXPERIENCED SYMPTOMS SUCH AS FEELING SICK. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538179 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6013436 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention