BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT

    MDR report key: 23355596 · Received October 22, 2025

    Report

    Report Number
    3003442380-2025-15136
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    August 25, 2025
    Report Date
    November 28, 2025
    Manufacturer
    UNOMEDICAL S.A DE C.V
    Product Code
    FPA
    UDI-DI
    05705244019645
    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 TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE THE BATCH 6012254, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DHR REVIEW: THE LOT 6012254 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 21 IN THE MULTIVAC 14, ON 18/MAR/2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: CANNULA. THE LOT 5C01081 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 17 AND MANUFACTURED IN THE MACHINE LC05, ON 11-MAR-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. 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 THE PATIENT REPORTED THAT INTRODUCER NEEDLE BENT DURING REMOVAL CAUSING BLEEDING AT THE SITE AND HARD TO REMOVE EVENT ON (B)(6) 2025. INFUSION SET WAS REMOVED RIGHT AWAY FROM THE BODY AFTER INSERTION. INSERTION SITE WAS ABDOMEN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233085 COMFORT UNO COMFORT SHORT 80/13 SC1 MINI FPA UNOMEDICAL S.A DE C.V MMT-383A 6012254 05705244019645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown