BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSTEEL

    MDR report key: 21985009 · Received May 8, 2025

    Report

    Report Number
    3003442380-2025-08359
    Event Type
    Injury
    Date Received
    May 8, 2025
    Date of Event
    March 28, 2025
    Report Date
    May 15, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018518
    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 THE INFORMATION IN THIS COMPLAINT 2192599 HAS BEEN EVALUATED FOR THE MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION. THE BATCH 6002652 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002652 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 94 PACKAGING IN THE MULTIVAC 10 ON 06/AUG/2023, 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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 14/MAY/2025 AGAINST MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION, HARM CODE INFECTION (REQUIRES ADVANCED MEDICAL INTERVENTION E.G., I.V. ANTIBIOTICS, SURGICAL DEBRIDEMENT OR EXCISION) AND LOT 6002652 AND NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO MALFUNCTION REPORTED, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, HARM CODE AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR 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 WENT TO EMERGENCY ROOM (ER) ON (B)(6) 2025 DUE TO THE INFECTION THAT WAS SITE RELATED. THE BLOOD GLUCOSE LEVEL WAS 459 MG/DL. THE PATIENT ALSO HAD A LARGE BUMP ON THE INSERTION SITE THAT WAS SUSPECTED TO HAVE BEEN CAUSED BY IFS (INFUSION SET) BEING INSERTED IN THE SKIN. THE PATIENT WAS TREATED BY HCP (HEALTH CARE PROFESSIONAL) WITH MANUAL INJECTION. THE PATIENT STAYED FOR FOUR HOURS IN THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981229 TRUSTEEL UNO CONTACT DETACH G29 80/8TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002836 6002652 05705244018518

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention