BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM PLUS SV-3

    MDR report key: 19872912 · Received July 31, 2024

    Report

    Report Number
    3008062894-2024-00003
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    January 26, 2021
    Report Date
    June 20, 2024
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "ON (B)(6) 2021 - THE DISTRIBUTOR REPORTED THAT A PATIENT HAD INGESTED A CAPSULE 4 WEEKS PRIOR BUT HAD NOT PASS IT. THE DISTRIBUTOR ALSO PROVIDED THE BRIEF PATIENT INFORMATION THAT (B)(6) 2021 X-RAY, (B)(6) 2021 X-RAY, AND (B)(6) 2021 CT SCAN SHOWED THE CAPSULE STILL IN THE PATIENT'S BODY, AND THE PATIENT HAS VENTRAL HERNIA. FRM-0089A CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE PHYSICIAN FOR MORE INFORMATION REGARDING THE RETENTION. CAPSOVISION KEPT FOLLOWING UP WITH THE PHYSICIAN FOR THE SN AND THE STATUS OF THE PATIENT ON (B)(6) 2021, (B)(6) 2021, AND (B)(6) 2021, HOWEVER, NO ADDITIONAL RESPONSE WAS PROVIDED ACCORDING TO CLINICAL SALES TRAINER & TERRITORY MANAGER OF THE DISTRIBUTOR, THE PATIENT HAD SURGERY ON HIS VENTRAL HERNIA AND THE CAPSULE WAS FOUND IN A STRICTURE IN THE BOWEL, WHICH WAS CREATED BY THE VENTRAL HERNIA. IT IS BELIEVED THAT THE RETENTION WAS CAUSED BY THE PATIENT'S PRE-EXISTING CONDITION."

    Description of Event or Problem · 0

    ON (B)(6) 2021 - THE DISTRIBUTOR REPORTED THAT A PATIENT HAD INGESTED A CAPSULE 4 WEEKS PRIOR BUT HAD NOT PASS IT. THE DISTRIBUTOR ALSO PROVIDED THE BRIEF PATIENT INFORMATION THAT (B)(6) 2021 X-RAY, (B)(6) 2021 X-RAY, AND (B)(6) 2021 CT SCAN SHOWED THE CAPSULE STILL IN THE PATIENT'S BODY, AND THE PATIENT HAS VENTRAL HERNIA. FRM-0089A CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE PHYSICIAN FOR MORE INFORMATION REGARDING THE RETENTION. CAPSOVISION KEPT FOLLOWING UP WITH THE PHYSICIAN FOR THE SN AND THE STATUS OF THE PATIENT ON (B)(6) 2021, (B)(6) 2021, AND (B)(6) 2021, HOWEVER, NO ADDITIONAL RESPONSE WAS PROVIDED ACCORDING TO CLINICAL SALES TRAINER & TERRITORY MANAGER OF THE DISTRIBUTOR, THE PATIENT HAD SURGERY ON HIS VENTRAL HERNIA AND THE CAPSULE WAS FOUND IN A STRICTURE IN THE BOWEL, WHICH WAS CREATED BY THE VENTRAL HERNIA. IT IS BELIEVED THAT THE RETENTION WAS CAUSED BY THE PATIENT'S PRE-EXISTING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239894 CAPSOCAM PLUS SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS CAPSULE NEZ CAPSOVISION, INC SV-3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention