BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT DETACH

    MDR report key: 23567319 · Received November 17, 2025

    Report

    Report Number
    3003442380-2025-16484
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    August 16, 2025
    Report Date
    November 19, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244025288
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    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 UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6012522, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 10-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6012522". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012522 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 101 AND MANUFACTURED IN THE MACHINE 14 ON 30-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. THE SUB-ASSEMBLY LOT 5C06002 WAS MANUFACTURED ACCORDING TO THE WI VERSION 67 AND MANUFACTURED IN THE MACHINE SC05 AND SC08, ON 30-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY LOT 5C04324 WAS MANUFACTURED ACCORDING TO THE WI VERSION 67 AND MANUFACTURED IN THE MACHINE SC05 AND SC08, ON 31-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 FOR THE CODE ADHESIVE PATCH ACCIDENTALLY DETACHES FROM SITE (E.G., RIPPED OUT, CAUGHT ON DOOR HANDLE, PULLED BY A PET, EXCESSIVE SWEATING, PROLONGED CONTACT WITH WATER, UNATTACHED DURING SLEEP OR SIMILAR MOVEMENT, ETC.). 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 THRESHOLD 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. IT WAS REPORTED THAT PATIENT FACED INFUSION ANCHOR ADHESIVE WAS NO LONGER STICKING TO THE BODY EVENT ON (B)(6) 2025. THE BLOOD GLUCOSE LEVELS WAS 399 MG/DL.PATIENT HAD TRACE KETONES PRESENT AND EXPERIENCED SYMTOMS LIKE NAUSEA. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2874122 CONTACT DETACH UNO CONTACT DETACH G29 60/6 BETA FPA UNOMEDICAL DEVICES S.A. DE C.V. FG000016-03 6012522 05705244025288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown