BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 12850171 · Received November 21, 2021

    Report

    Report Number
    3009862700-2021-00139
    Event Type
    Injury
    Date Received
    November 21, 2021
    Date of Event
    October 22, 2021
    Report Date
    October 22, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491022349
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT NOTICED ABOUT 1.5 HOURS AFTER THE REMOVAL PROCEDURE THE INCISION WAS BLEEDING THROUGH HER TEGADERM. PATIENT'S HUSBAND TOOK OFF THE COBAN, AND TEGADERM AND STERI-STRIPS HAD FALLEN OFF. USER VISITED EMERGENCY ROOM. ER ATTEMPTED TO STOP THE BLEEDING BY APPLYING DERMABOND AND A PRESSURE DRESSING. IT CONTINUED TO BLEED THROUGH. ER PLACED A STAPLE TO HER INCISION THAT COMPLETELY STOPPED THE BLEEDING. PATIENT WAS PRESCRIBED WITH KEFLEX AND IS DOING FINE AND NO FURTHER ACTIONS TO BE TAKEN.

    Description of Event or Problem · 0

    ON OCTOBER 21ST 2021, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE PATIENT NOTICED ABOUT 1.5 HOURS AFTER THE REMOVAL PROCEDURE THE INCISION WAS BLEEDING THROUGH HER TEGADERM. PATIENT'S HUSBAND TOOK OFF THE COBAN, AND TEGADERM AND STERI-STRIPS HAD FALLEN OFF. USER VISITED EMERGENCY ROOM. ER ATTEMPTED TO STOP THE BLEEDING BY APPLYING DERMABOND AND A PRESSURE DRESSING. IT CONTINUED TO BLEED THROUGH. ER PLACED A STAPLE TO HER INCISION THAT COMPLETELY STOPPED THE BLEEDING. PATIENT WAS PRESCRIBED WITH KEFLEX AND IS DOING FINE AND NO FURTHER ACTIONS TO BE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747731 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102096-67A WP08507 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Hospitalization