BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM SV-3

    MDR report key: 19722189 · Received July 11, 2024

    Report

    Report Number
    3008062894-2024-00037
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    March 15, 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
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    3/27/2023 - PATIENT HAD THEIR CAPSULE PROCEDURE DONE ON (B)(6) AND HAS NOT COME BACK YET, CUSTOMER IS PLANNING TO SEND THE PATIENT FOR IMAGINING. 4/24/2023 - WE WERE NOTIFIED THAT THE PATIENT WILL NOT ANSWER CALLS FROM THE CLINIC. 5/10/2023 - CUSTOMER INFORMED US THAT THE PATIENT HAS A HISTORY OF BEING NON-COMPLIANT. THEY HAVE CALLED HER AND SENT HER A LETTER. SHE HAS NOT RESPONDED. SINCE THE CUSTOMER IS UNSUCCESSFUL TO REACH THE PATIENT AFTER MULTIPLE ATTEMPTS, THIS COMPLAINT WAS CLOSED AND WILL BE RE-OPENED IF ANY FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    "3/27/2023 - PATIENT HAD THEIR CAPSULE PROCEDURE DONE ON (B)(6) AND HAS NOT COME BACK YET, CUSTOMER IS PLANNING TO SEND THE PATIENT FOR IMAGINING. 4/24/2023 - WE WERE NOTIFIED THAT THE PATIENT WILL NOT ANSWER CALLS FROM THE CLINIC. 5/10/2023 - CUSTOMER INFORMED US THAT THE PATIENT HAS A HISTORY OF BEING NON-COMPLIANT. THEY HAVE CALLED HER AND SENT HER A LETTER. SHE HAS NOT RESPONDED. SINCE THE CUSTOMER IS UNSUCCESSFUL TO REACH THE PATIENT AFTER MULTIPLE ATTEMPTS, THIS COMPLAINT WAS CLOSED AND WILL BE RE-OPENED IF ANY FURTHER INFORMATION IS RECEIVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385085 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-22-0221

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other