BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT DETACH

    MDR report key: 23389267 · Received October 27, 2025

    Report

    Report Number
    3003442380-2025-15405
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    September 27, 2025
    Report Date
    June 6, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNOMEDICAL HEREBY SUBMITS THIS SUPPLEMENTAL REPORT AS PART OF ITS COMPLAINT REMEDIATION ACTIVITIES CONDUCTED UNDER A CAPA/FDA ACTION PLAN. THIS SUBMISSION INCLUDES A RETROSPECTIVE REASSESSMENT OF PREVIOUSLY EVALUATED COMPLAINTS. UNOMEDICAL IS PROVIDING THIS SUPPLEMENTAL INFORMATION IN ACCORDANCE WITH THE REPORTING REQUIREMENTS SET FORTH IN 21 CFR PART 803. ANY FIELDS LEFT BLANK INDICATE THAT THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR REMAINS UNCHANGED. MDR RETRACTION: THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-15405), WAS SUBMITTED ON 27-OCT-2025. HOWEVER, BASED ON THE INVESTIGATION DONE ON 18-JAN-2026 AND CLINICAL REVIEW DONE ON 23-JAN-2026, IT WAS FOUND THAT THE SERIOUS INJURY WAS NOT RELATED TO THE INFUSION SET AND THERE IS NO ALLEGATION ON UNOMEDICAL PRODUCTS. NOW, THIS CASE HAS BEEN DETERMINED TO BE NON-REPORTABLE. HENCE, THIS MDR IS BEING SUBMITTED TO RETRACT THE INITIAL MDR. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    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 INFECTION AT THE INSERTION SITE ON (B)(6) 2025. PATIENT DISCUSSED WITH HEALTH CARE PROFESSIONAL (HCP) AND MEDICATION WAS PRESCRIBED. THE INFUSION SET WAS IN USE FOR TWO DAYS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2741441 CONTACT DETACH UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002833 UNKNOWN 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female Required Intervention