BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB3 CAPSULE

    MDR report key: 5003514 · Received August 12, 2015

    Report

    Report Number
    9710107-2015-00220
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    August 10, 2015
    Report Date
    January 14, 2016
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K123864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PATIENT SWALLOWED A PILLCAM CAPSULE AND IT WAS STUCK IN THE THROAT. THE PHYSICIAN PERFORMED AN UPPER ENDOSCOPY BUT WAS NOT ABLE TO RETRIEVE THE CAPSULE. THE CAPSULE WAS PUSHED DOWN INTO THE PATIENT'S STOMACH. NO HARM WAS CAUSED TO THE PATIENT. PATIENT HAD A STRICTURE IN THE ESOPHAGUS AND THE PHYSICIAN BELIEVES THIS IS THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529173 PILLCAM SB3 CAPSULE PILLCAM SB CAPSULE NEZ GIVEN IMAGING LTD. FGS-0501

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention