BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFORT

    MDR report key: 23230786 · Received October 7, 2025

    Report

    Report Number
    3003442380-2025-14378
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 6, 2025
    Report Date
    September 22, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K162812
    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 6012740, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 09-SEP-2025 AGAINST FINAL REPORTING DECISION EQUAL SERIOUS INJURY AND DEATH, LOT NUMBER CRITERIA EQUAL LOT NUMBER 6012740. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012740 WAS PACKAGED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC 14 ON 21-APR-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT DURING THE FINAL INSPECTION OUTGOING, TEST NUM 9: A SAMPLE WAS FOUND WITH TUBING TRAPPED IN SEAL. DUE TO THE ORDER QUANTITY, A SAMPLING PLAN WAS NOT NECESSARY, THE BATCH WAS RELEASED. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, THE RETURNED SAMPLE(S) FROM THE LOT HAVE BEEN REQUESTED NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, HOWEVER, DURING THE FINAL INSPECTION OUTGOING, TEST NUM 9: A SAMPLE WAS FOUND WITH TUBING TRAPPED IN SEAL. DUE TO THE ORDER QUANTITY, A SAMPLING PLAN WAS NOT NECESSARY, THE BATCH WAS RELEASED, 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. 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 6012740, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 09-SEP-2025 AGAINST FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", LOT NUMBER CRITERIA EQUAL LOT NUMBER 6012740. THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012740 WAS PACKAGED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MULTIVAC M14 ON 21-APR-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT DURING THE FINAL INSPECTION OUTGOING, TEST NUM 9: A SAMPLE WAS FOUND WITH TUBING TRAPPED IN SEAL. DUE TO THE ORDER QUANTITY, A SAMPLING PLAN WAS NOT NECESSARY, THE BATCH WAS RELEASED. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. TEST RESULTS: NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, HOWEVER, DURING THE FINAL INSPECTION OUTGOING, TEST NUM 9: A SAMPLE WAS FOUND WITH TUBING TRAPPED IN SEAL. DUE TO THE ORDER QUANTITY, A SAMPLING PLAN WAS NOT NECESSARY, THE BATCH WAS RELEASED, 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.

    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. ON (B)(6) 2025 AT 8:00 PM, PATIENT WAS ADMITTED TO HOSPITAL DUE TO A SEVERE HYPERGLYCEMIC EPISODE. PRIOR TO ADMISSION, THE PATIENT REPORTED FEELING EXTREMELY UNWELL AND EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA INCLUDING FATIGUE, WEAKNESS, AND INCREASED THIRST. UPON ARRIVAL AT THE HOSPITAL, THE PATIENT'S SENSOR GLUCOSE READING WAS ELEVATED AT 472 MG/DL, AND KETONE RESULTS INDICATED BORDERLINE DIABETIC KETOACIDOSIS (DKA). DURING HOSPITALIZATION, THE PATIENT RECEIVED INTRAVENOUS FLUIDS AND ADMINISTERED INSULIN VIA MANUAL INJECTIONS. AFTER SPENDING LESS THAN TWENTY FOUR HOURS IN THE HOSPITAL, THE PATIENT WAS RELEASED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2690522 COMFORT UNO COMFORT SHORT 110/13 SC1 MINI FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-382A 6012740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention