BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT

    MDR report key: 23355475 · Received October 22, 2025

    Report

    Report Number
    3003442380-2025-15261
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 25, 2025
    Report Date
    November 6, 2025
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019553
    PMA / PMN Number
    K162812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    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 6011967 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011967 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 21 AND PACKAGING IN THE MULTIVAC 10, ON 02/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, CANNULA THE LOT 5B01561 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 16 CANNULA IN THE MACHINE LS04, ON 26/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, CANNULA THE LOT 5B03600 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 16 CANNULA IN THE MACHINE LS04, ON 18/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, CANNULA THE LOT 5B01562 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 17 CANNULA IN THE MACHINE LS04, ON 01/MAR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, CANNULA THE LOT 5A07169 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 17 CANNULA IN THE MACHINE LS04, ON 03/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBING THE LOT 5B01545 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 17 IN THE GLUING TUBING IN THE LC01, ON 28/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBING THE LOT 5B01544 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 17 IN THE GLUING TUBING IN THE SC05 AND SC06, ON 28/MAR/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. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET DETACHMENT EVENT ON (B)(6) 2025. THE SITE OF DETACHMENT WAS TUBING CONNECTOR. THE INFUSION SET WAS IN USE FOR LESS THAN ONE DAY. INSERTION SITE WAS LEFT ABDOMEN. THE BLOOD GLUCOSE LEVEL WAS 400 MG/DL AND THE PATIENT WAS TREATED WITH MANUAL INJECTION/INSULIN PEN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447435 COMFORT UNO COMFORT 60/17 SC1 MINI FPA UNOMEDICAL S.A. DE C.V. MMT-378A 6011967 05705244019553

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown