BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFORT

    MDR report key: 23421538 · Received October 30, 2025

    Report

    Report Number
    3003442380-2025-15477
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 4, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019553
    PMA / PMN Number
    K162812
    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 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 6011967, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 20-OCT-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL 6011967. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011967 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 21 AND MANUFACTURED IN THE MULTIVAC M14 ON 02-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE GLUING OF TUBING OF THE LOT # 5B01544 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 17 AND MANUFACTURED IN THE GLUING MACHINE LC02, ON 02-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE GLUING OF TUBING OF THE LOT # 5B01545 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 17 AND MANUFACTURED IN THE GLUING MACHINE LC01, ON 28-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCE (NC) WAS OPENED FOR CONTAMINATION IN THE INSET LINE 6 PROCESS AND FURTHER PRODUCT DISPOSITION WERE REQUIRED. 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: - WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TEST FOR COMPLAINTS AREA VERSION 3: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. - WORK INSTRUCTION (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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, ONE NON-CONFORMANCE (NC) RAISED DURING PRODUCTION UNRELATED 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 GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA EVENT. BLOOD GLUCOSE LEVEL WAS 530 MG/DL AT THE TIME OF THE EVENT AND PATIENT GOT TREATED WITH BOLUS OTHER THAN INSULIN.THE DURATION OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379668 COMFORT UNO COMFORT 60/17 SC1 MINI FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-378A 6011967 05705244019553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R