BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 22857554 · Received August 21, 2025

    Report

    Report Number
    3003442380-2025-13042
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    July 16, 2025
    Report Date
    September 2, 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

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

    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 SUMMARYZ: COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011034, IN QUESTION WAS MANUFACTURED AT THE REYNOSA ID SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 02-SEP-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6011034". IF THE COUNT OF COMPLAINTS EQUALS OR EXCEEDS 5, FURTHER INVESTIGATION IS REQUIRED VIA CAPA DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS. THE COMPLAINT NUMBERS ARE: (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011034 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MACHINE 12 ON 11-JAN-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: TUBING OF THE LOT 5A01008 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED, ON 10-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. TUBING OF THE LOT 5A01009 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED, ON 10-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. TUBING OF THE LOT 5A01010 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED, ON 11-JAN-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 WAS PROVIDED. IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE FROM THE LOT HAVE BEEN REQUESTED. NO PHYSICAL SAMPLES WERE RETURNED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, FIVE COMPLAINTS THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, NO FURTHER ACTIONS ARE REQUIRED ARE MET FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT REQUIRES FURTHER CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA AND GOT TREATED WITH INTRAVENOUS (IV) DRIP. BLOOD GLUCOSE LEVEL WAS 590 MG/DL AT THE TIME OF THE EVENT AND WAS CAUSED BY OCCLUSION ALARM. PATIENT WAS FOUND POSITIVE FOR KETONES. THE PATIENT ALSO EXPERIENCED SYMPTOMS OF FEELING SICK/ UNWELL AND INCREASED THIRST. THE LENGTH OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203657 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6011034 05705244017450

    Patients

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