BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT DETACH

    MDR report key: 23551881 · Received November 14, 2025

    Report

    Report Number
    3003442380-2025-16195
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    August 3, 2025
    Report Date
    November 13, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244025288
    PMA / PMN Number
    K041545
    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 6008881, IN QUESTION WAS MANUFACTURED AT THE: REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 13-NOV-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH" , "LOT NUMBER" CRITERIA EQUAL "6008881". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6008881 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 98 AND MANUFACTURED IN THE MULTIVAC 14 ON 16-SEP-2024, 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. GLUING OF TUBING OF THE LOT 4H05787 MANUFACTURED IN THE MACHINE SC05, SC06, ON 31-AUG-2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 4J03033 MANUFACTURED IN THE MACHINE SC05, SC06, ON 16-SEP-2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING OF THE LOT 4J03034 MANUFACTURED IN THE MACHINE SC05, SC06, ON 17-SEP-2024, 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. WELDING: THE LOT 4J02645 WAS WELDING ACCORDING TO THE WI 4905092 VERSION 34, MANUFACTURED IN THE LINE LS06, LS07, ON 14/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4J03024 WAS WELDING ACCORDING TO THE WI 4905092 VERSION 34, MANUFACTURED IN THE LINE LS06, LS07, ON 16/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4J03026 WAS WELDING ACCORDING TO THE WI 4905092 VERSION 34, MANUFACTURED IN THE LINE LS24, LS25, ON 17/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4J03025 WAS WELDING ACCORDING TO THE WI 4905092 VERSION 34, MANUFACTURED IN THE LINE LS24, LS25, ON 16/SEP/2024 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. GLUING CONNECTOR: THE LOT 4J02642 WAS GLUED ACCORDING TO THE WI 4905088 VERSION 37, MANUFACTURED IN THE LINE L-3 ON 13/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4J02376 WAS GLUED ACCORDING TO THE WI 4905088 VERSION 37, MANUFACTURED IN THE LINE L-3 ON 19/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4J03018 WAS GLUED ACCORDING TO THE WI 4905088 VERSION 37, MANUFACTURED IN THE LINE L-3 ON 15/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4J03150 WAS GLUED ACCORDING TO THE WI 4905088 VERSION 37, MANUFACTURED IN THE LINE L-3 ON 16/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4J03015 WAS GLUED ACCORDING TO THE WI 4905088 VERSION 37, MANUFACTURED IN THE LINE L-3 ON 15/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4J03019 WAS GLUED ACCORDING TO THE WI 4905088 VERSION 37, MANUFACTURED IN THE LINE L-3 ON 17/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4J03151 WAS GLUED ACCORDING TO THE WI 4905088 VERSION 37, MANUFACTURED IN THE LINE L-3 ON 17/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4J03152 WAS GLUED ACCORDING TO THE WI 4905088 VERSION 37, MANUFACTURED IN THE LINE L-3 ON 17/SEP/2024 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: IN ORDER TO TEST THE PRODUCT, NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED, THEREFORE, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED, HOWEVER, THE REFERENCE SAMPLES FOR THE LOT 6008881 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 09-JUN-2025. 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 FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST FOR THE CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TEST OF REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, 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 OCCURED IN UNITED STATES. IT WAS REPORTED THAT THE PATIENT HAD ELEVATED BLOOD GLUCOSE LEVEL ON (B)(6) 2025, WITH SYMPTOMS INCLUDING VOMITING, HEART BEATING FAST AND HEADACHE. THE BLOOD GLUCOSE LEVEL WAS OVER 400MG/DL AND HAD HIGH KETONES AT THE TIME OF EVENT. THE PATIENT GOT TREATED WITH INSULIN SHOT OF 7 UNITS AND CHANGED ALL THE SUPPLIES. THE BLOOD GLUCOSE CAME DOWN TO 223MG/DL AND THE KETONES WERE SMALL TO MODERATE RANGE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928906 CONTACT DETACH UNO CONTACT DETACH G29 60/6 BETA FPA UNOMEDICAL DEVICES S.A. DE C.V. FG000016-03 6008881 05705244025288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention