BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSOCAM SV-3

    MDR report key: 19722405 · Received July 11, 2024

    Report

    Report Number
    3008062894-2024-00033
    Event Type
    Death
    Date Received
    July 11, 2024
    Date of Event
    November 4, 2021
    Report Date
    July 10, 2024
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "DURING THE INVESTIGATION OF A NOT-MAILED-IN CAPSULE WHICH PERFORMED IN OCTOBER,2021, THE SALES FOUND THIS PATIENT HAD PASSED AWAY NOT SURE WHEN. HE ALSO MENTIONED THAT THEY DIDN'T SEEM TO BELIEVE THAT IT WAS CAPSULE RELATED. PER FRM-0089 CAPSULE INCIDENT QUESTIONNAIRE THE CUSTOMER PROVIDED, THE IMAGING TAKEN ON (B)(6) 2021 CONFIRMED THE CAPSULE HAD PASSED AND WAS NOT RETAINED. IT IS BELIEVED THAT THE PATIENT EXCRETED THE CAPSULE NATURALLY BUT WAS UNABLE TO RETRIEVE IT."

    Description of Event or Problem · 0

    DURING THE INVESTIGATION OF A NOT-MAILED-IN CAPSULE WHICH PERFORMED IN OCTOBER,2021, THE SALES FOUND THIS PATIENT HAD PASSED AWAY NOT SURE WHEN. HE ALSO MENTIONED THAT THEY DIDN'T SEEM TO BELIEVE THAT IT WAS CAPSULE RELATED. PER FRM-0089 CAPSULE INCIDENT QUESTIONNAIRE THE CUSTOMER PROVIDED, THE IMAGING TAKEN ON (B)(6) 2021 CONFIRMED THE CAPSULE HAD PASSED AND WAS NOT RETAINED. IT IS BELIEVED THAT THE PATIENT EXCRETED THE CAPSULE NATURALLY BUT WAS UNABLE TO RETRIEVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341015 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-21-0097

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Death