BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23081014 · Received September 18, 2025

    Report

    Report Number
    3003442380-2025-13932
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    August 13, 2025
    Report Date
    August 22, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    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: GERMANY. 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 6012574, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 09-SEP-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6012574". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010154 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 12 ON 02-APR-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: IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED. NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. 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 GERMANY. IT WAS REPORTED THAT THE PATIENT FACED HYPERGLYCAEMIA EVENT AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS 574 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS INSULIN INJECTION. THE PATIENT HAD KETONES AND SYMPTOMS LIKE BLURRED SIGHT AND UNABLE TO WALK. LENGTH OF HOSPITALIZATION WAS FOR 3 DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634848 QUICK SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6012574 05705244017573

    Patients

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