BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT DETACH

    MDR report key: 24785421 · Received April 4, 2026

    Report

    Report Number
    3003442380-2026-88910
    Event Type
    Injury
    Date Received
    April 4, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 7, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244025288
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURED IN UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ADHESIVE MALFUNCTION EVENT ON (B)(6) 2026, AS THE CUSTOMER STATED THAT INFUSION SET FALL OFF DUE TO POOR ADHESION. THE BLOOD GLUCOSE LEVEL WAS 372 MG/DL. THE PATIENT HAD MEAL TO BRING THE BLOOD GLUCOSE LEVEL DOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845444 CONTACT DETACH UNO CONTACT DETACH G29 60/6 BETA FPA UNOMEDICAL UM-D FG000016-03 UNKNOWN 05705244025288

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention