BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSOCAM SV-3

    MDR report key: 19722471 · Received July 11, 2024

    Report

    Report Number
    3008062894-2024-00039
    Event Type
    Death
    Date Received
    July 11, 2024
    Date of Event
    May 2, 2023
    Report Date
    July 10, 2024
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "(B)(6) 2023 - CAPSULE WAS NOT RETRIEVED. PATIENT ULTIMATELY WAS ADMITTED TO HOSPITAL AND DIED FROM UNRELATED CIRCUMSTANCES. 5/22/2023 - THE CUSTOMER SENT THE FRM-89 WHICH INDICATED THAT THE PATIENT DIED FROM UNRELATED CIRCUMSTANCES."

    Description of Event or Problem · 0

    (B)(6) 2023 - CAPSULE WAS NOT RETRIEVED. PATIENT ULTIMATELY WAS ADMITTED TO HOSPITAL AND DIED FROM UNRELATED CIRCUMSTANCES. 5/22/2023 - THE CUSTOMER SENT THE FRM-89 WHICH INDICATED THAT THE PATIENT DIED FROM UNRELATED CIRCUMSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348608 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-22-0277

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death