BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM

    MDR report key: 19439631 · Received May 31, 2024

    Report

    Report Number
    9710107-2024-00086
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    May 6, 2024
    Report Date
    May 31, 2024
    Manufacturer
    GIVEN IMAGING LTD., YOQNEAM
    Product Code
    NEZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K892432. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE CAPSULE WAS INGESTED BY THE PATIENT ON FRIDAY, MAY 3RD, BUT IT WAS NOT DISSOLVED AND HAD TO BE RETRIEVED ON MAY 6TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332587 PILLCAM SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C NEZ GIVEN IMAGING LTD., YOQNEAM FGS-0660 61606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention