BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT DETACH

    MDR report key: 23628128 · Received November 23, 2025

    Report

    Report Number
    3003442380-2025-16687
    Event Type
    Injury
    Date Received
    November 23, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 20, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244019348
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED MANUFACTURING DATE UNDER H4. 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 6012096, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 19-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6012096". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012096 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 100 AND MANUFACTURED IN THE MACHINE 14 ON 10-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY LOT 5B03045 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINE LS06 AND LS07, ON 08-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY LOT 5B03032 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 AND MANUFACTURED IN THE MACHINE LS24 AND LS25, ON 02-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING OF THE LOT 5C01436 WAS MANUFACTURED ACCORDING TO THE WI VERSION 67 AND MANUFACTURED IN THE MACHINE FT02, ON 09-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF TUBING OF THE LOT 4B03510 WAS MANUFACTURED ACCORDING TO THE WI VERSION 60 AND MANUFACTURED IN THE MACHINE FT02, ON 21-FEB-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF CONNECTOR OF THE LOT 5C01350 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE 03, ON 08-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY GLUING OF CONNECTOR OF THE LOT 5C01349 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 AND MANUFACTURED IN THE MACHINE 03, ON 08-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. TEST RESULTS: NO PHOTO WAS PROVIDED. IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST AND WI GUIDANCE FOR FUNCTIONAL TESTING FLOW FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST WI GUIDANCE FOR FUNCTIONAL TESTING LEAK FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE IDD-PMC11.03 NO MALFUNCTION BASED ON COMPLAINT INFORMATION. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, ONE COMPLAINT NO THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, 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 OCCURED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED ON (B)(6) 2025 THE BLOOD GLUCOSE LEVEL WAS 400MG/DL AND THE PATIENT GOT TREATED WITH MANUAL INJECTION AND INTRAVENOUS.THE PATIENT WAS IN THE HOSPITAL FOR LESS THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567751 CONTACT DETACH UNO CONTACT DETACH G29 80/6 SC1 MIMX FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-866A 6012096 05705244019348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown