BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 22910942 · Received August 28, 2025

    Report

    Report Number
    3003442380-2025-13268
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 2, 2025
    Report Date
    August 30, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017931
    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 ARAB EMIRATES.

    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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6001151, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 28-AUG-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6001151. THE COUNT OF COMPLAINT IS 4 WHICH IS EXCEEDS 3. FURTHER INVESTIGATION IS REQUIRED VIA CORRECTIVE AND PREVENTIVE ACTION (CAPA). DETERMINATION ASSESSMENT USING STATISTICAL ANALYSIS. THE COMPLAINT NUMBERS ARE: (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001151 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 AND MANUFACTURED IN THE MULTIVAC 12 ON 26-APR-2023, 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 SAMPLES 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, THE THRESHOLDS OF 4 REPORTABLE COMPLAINTS 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 ARAB EMIRATES. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS (DKA) EVENT. BLOOD GLUCOSE LEVEL WAS 514 MG/DL AT THE TIME OF THE EVENT AND PATIENT GOT TREATED WITH INTRAVENOUS (IV) DRIP. PATIENT ALSO EXPERIENCED THE SYMPTOMS OF ABDOMINAL PAIN, DRYNESS AT THE TIME OF THE EVENT. THE DURATION 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
    2519798 QUICK SET UNO QUICK-SET 110/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-398A 6001151 05705244017931

    Patients

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