BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23739153 · Received December 8, 2025

    Report

    Report Number
    3003442380-2025-16888
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    October 15, 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
    003

    Narratives

    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 6013446, 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 6013446. THE COUNT OF COMPLAINT IS 3 WHICH IS EXCEEDS 3. FURTHER INVESTIGATION IS REQUIRED VIA CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS. THE COMPLAINTS NUMBER ARE: (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013446 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC M12 ON 22-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 5E03505 WAS MANUFACTURED ACCORDING TO THE WI VERSION 30 AND MANUFACTURED IN THE QUICKSET LINE, ON 22-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE ASSEMBLY, LOT 5E03506 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 5E03422 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE MP04 - MP08, ON 21-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY. GLUING OF TUBING OF THE LOT 5E01608 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE MP04 - MP08, ON 18-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 VERSION 42 AND MANUFACTURED IN THE GLUING MACHINE MP04 - MP08, ON 22-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: 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, THE THRESHOLDS OF 3 REPORTABLE COMPLAINTS ARE MET FOR THE LOT IN QUESTION AND MALFUNCTION CODE; FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT REQUIRES FURTHER CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT.

    Additional Manufacturer Narrative · 0

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

    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 STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HIGH BLOOD GLUCOSE (BG) EVENT AFTER ATTENDING A BIRTHDAY PARTY, DURING WHICH HE CONSUMED MORE CARBOHYDRATES THAN USUAL. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM (ER) AND WAS HOSPITALIZED ON (B)(6) 2025. THE BLOOD GLUCOSE (BG) LEVEL WAS 267 MG/DL, WITH SYMPTOMS INCLUDING FEELING SICK/UNWELL AND TIRED/WEAK. THE PATIENT WAS TREATED WITH INSULIN ADMINISTRATION VIA INTRAVENOUS (IV) DRIP. THE LENGTH OF HOSPITALIZATION WAS MORE THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449186 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6013446 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R