BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23241994 · Received October 8, 2025

    Report

    Report Number
    3003442380-2025-14653
    Event Type
    Injury
    Date Received
    October 8, 2025
    Date of Event
    August 27, 2025
    Report Date
    September 24, 2025
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    FPA
    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: 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 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 23-SEP-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6013446. THE COUNT OF COMPLAINT IS 2 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013446 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN MULTIVAC M12 ON 22-MAY-2025, 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 TESTING IS REQUIRED FOR MALFUNCTION BASED ON COMPLAINT INFORMATION. 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, NO TREND IDENTIFIED FOR THE LOT IN QUESTION, 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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) FOR HYPOGLYCEMIA ON (B)(6) 2025 FOR MORE THAN 24 HOURS. THE PATIENT BLOOD GLUCOSE LEVEL WAS 50 MG/DL. PATIENTS WERE TREATED WITH EATING SOMETHING. 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
    2481357 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL S.A. DE C.V. MMT-397A 6013446

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization