BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSET

    MDR report key: 23422288 · Received October 30, 2025

    Report

    Report Number
    3003442380-2025-15494
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    September 22, 2025
    Report Date
    October 22, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244026032
    PMA / PMN Number
    K032854
    Adverse Event
    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 6011715, 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 6011715. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DHR REVIEW: THE LOT 6011715 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 13 AND MANUFACTURED IN THE LINE INSET 6 ON 15-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE GLUING OF TUBING OF THE LOT 5B01679 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 AND MANUFACTURED IN THE GLUING MACHINE SC09, ON 11-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE GLUING OF TUBING OF THE LOT 5A06566 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 AND MANUFACTURED IN THE GLUING MACHINE SC04, ON 30-JAN-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT A NON-CONFORMANCE NC-2165520 WAS OPENED DURING THE STERILIZATION 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: WI GUIDANCE FOR VISUAL TEST FOR COMPLAINTS AREA VERSION 3: ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. 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 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 VISITED EMERGENCY ROOM (ER) ON (B)(6) 2025 DUE TO HIGH BLOOD GLUCOSE LEVELS. THE PATIENT STAYED IN THE EMERGENCY ROOM (ER) FOR 4 HOURS. PATIENT ALSO HAD AN OPEN BRUISE ON HER BACK SHOULDER, A CUT ON HER NECK, AND A SORE ON HER NECK. THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. THE PATIENT REPLACED SUPPLIES AS NECESSARY AND RESUME INSULIN THERAPY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409321 INSET INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL DEVICES S.A. DE C.V. 1010899 6011715 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention