BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSOCAM SV-3

    MDR report key: 19697783 · Received July 8, 2024

    Report

    Report Number
    3008062894-2024-00030
    Event Type
    Death
    Date Received
    July 8, 2024
    Date of Event
    February 9, 2023
    Report Date
    July 8, 2024
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6)2023 - WE WERE NOTIFIED OF A PATIENT WHO SWALLOWED THE CAPSULE ON (B)(6)2023. HOWEVER, HE NEVER RETURNED THE CAPSULE, THE CUSTOMER TRIED SEVERAL TIMES TO REACH THE PATIENT WITH NO LUCK. THE PATIENT DIED ON (B)(6)2023. IT IS UNKNOWN IF THE PATIENT PASSED THE CAPSULE OR NOT. BASED ON THE EMAIL FROM A GI PHYSICIAN ((B)(6)2024) STARING THAT IT IS UNLIKELY THAT THE CAPSULE WOULD HAVE ANY CAUSAL RELATION TO THE PATIENTS CARDIAC ARREST, SINCE THE REAL CAUSE IN UNKNOWN IT WILL THE REPORTED.

    Description of Event or Problem · 0

    (B)(6)2023 - WE WERE NOTIFIED OF A PATIENT WHO SWALLOWED THE CAPSULE ON (B)(6)2023. HOWEVER, HE NEVER RETURNED THE CAPSULE, THE CUSTOMER TRIED SEVERAL TIMES TO REACH THE PATIENT WITH NO LUCK. THE PATIENT DIED ON (B)(6)2023. IT IS UNKNOWN IF THE PATIENT PASSED THE CAPSULE OR NOT. BASED ON THE EMAIL FROM A GI PHYSICIAN ((B)(6)/2024) STARING THAT IT IS UNLIKELY THAT THE CAPSULE WOULD HAVE ANY CAUSAL RELATION TO THE PATIENTS CARDIAC ARREST, SINCE THE REAL CAUSE IN UNKNOWN IT WILL THE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391612 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-22-0296

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death