BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM SV-3

    MDR report key: 19722213 · Received July 11, 2024

    Report

    Report Number
    3008062894-2024-00042
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    March 12, 2024
    Report Date
    July 11, 2024
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "(B)(6) 2024 - WE WERE INFORMED OF A CAPSULE THAT WAS NOT RETRIEVED, AFTER IT BEING STUCK FROM (B)(6) 2024 TO (B)(6) 2024, ON (B)(6) 2024 A COLONOSCOPY WAS DONE CONFIRMING THE EXCRETION OF THE CAPSULE. (B)(6) 2024 - A REPLACEMENT CAPSULE WAS SENT TO THE CUSTOMER."

    Description of Event or Problem · 0

    "(B)(6) 2024 - WE WERE INFORMED OF A CAPSULE THAT WAS NOT RETRIEVED, AFTER IT BEING STUCK FROM (B)(6) 2024 TO (B)(6) 2024, ON (B)(6) 2024 A COLONOSCOPY WAS DONE CONFIRMING THE EXCRETION OF THE CAPSULE. (B)(6) 2024 - A REPLACEMENT CAPSULE WAS SENT TO THE CUSTOMER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386100 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-23-0297

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other