BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB 3 CAPSULE, 1-PACK

    MDR report key: 6010685 · Received October 7, 2016

    Report

    Report Number
    9710107-2016-01033
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 16, 2016
    Report Date
    October 5, 2016
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    NEZ
    PMA / PMN Number
    K123864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT INGESTED A CAPSULE AND IT GOT STUCK IN THE ESOPHAGUS. THE PATIENT PREVIOUSLY HAD A GASTRIC-BAND. THE CUSTOMER WILL PERFORM AN EGD AND TRY TO REMOVE THE CAPSULE ALSO IT LOCATION TO SEE IF IT HAS MOVED. THE ACCOUNT CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT. A REPEAT PROCEDURE WAS NOT PERFORMED. FOLLOW UP INFORMATION REVEALED THAT THE TREATING DOCTOR REMOVED THE FIRST CAPSULE ENDOSCOPICALLY AND TRIED TO PLACE A SECOND CAPSULE AT THE SAME TIME. HE WAS UNABLE TO PLACE THE SECOND CAPSULE ALSO DUE TO THE GASTRIC BANDING. POST-ENDOSCOPE, THE PATIENT RECOVERED, DID NOT REQUIRE ANY ADDITIONAL MEDICAL INTERVENTION AND WAS DISCHARGED TO HOME DOING WELL. NO OTHER KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663276 PILLCAM SB 3 CAPSULE, 1-PACK SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ GIVEN LTD (ISRAEL) FGS-0501

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention