BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT

    MDR report key: 23787189 · Received December 12, 2025

    Report

    Report Number
    3003442380-2025-17353
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 28, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019614
    PMA / PMN Number
    K162812
    Product Problem
    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 TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. THE BATCH 6012978 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DHR REVIEW: THE LOT 6012978 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 21 AND PACKAGING IN THE MULTIVAC 14, ON 12/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, CANNULA PART THE LOT 5D01893 WAS MANUFACTURED ACCORDING TO THE WI VERSION 17 WELDING IN THE MACHINE LC04, ON 30/APR/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 5D01871 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 17 AND MANUFACTURED IN THE MACHINE LC01, ON 09/APR/2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE 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 NOTE: NON-CONFORMANCE (NC) IS 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 CAPA PLAN. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON (B)(6) 2025. 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
    506148 COMFORT UNO COMFORT SHORT 110/13 SC1 MINI FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-382A 6012978 05705244019614

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown