BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19256448 · Received May 6, 2024

    Report

    Report Number
    3003442380-2024-00680
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Report Date
    July 25, 2024
    Product Code
    FPA
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H11: INVESTIGATION SUMMARY: THE FOLLOWING TESTS WERE COMPLETED FOR 10 REFERENCE SAMPLES OF LOT 6003366: 1.VISUAL INSPECTION AS PER ACCEPTANCE AND REJECTION CRITERIA FOR ADHESIVE TAPE. DOC (CRITERIOS DE ACEPTACIÓN Y RECHAZO DE LA CINTA ADHESIVA.DOC), VERSION 18. 10 SAMPLES VISUALLY INSPECTED AND NO DAMAGES OR DELAMINATION IN THE ADHESIVE TAPE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. THE PATIENT REPORTED THAT THE INFUSION SET FELL OFF DURING USE. THE INFUSION WAS USED FOR FEW HOURS. THE PATIENT REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439307 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA 6003366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown