BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTPILL GI MONITORING SYSTEM

    MDR report key: 1590928 · Received January 26, 2010

    Report

    Report Number
    1320877-2010-00001
    Event Type
    Injury
    Date Received
    January 26, 2010
    Date of Event
    December 10, 2009
    Report Date
    January 26, 2010
    Manufacturer
    THE SMARTPILL CORPORATION
    Product Code
    NYV
    PMA / PMN Number
    K092342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) - DEVICE LODGED BECAUSE OF PT PHYSIOLOGY.

    Description of Event or Problem · 1

    PT UNDERWENT CAPSULE MOTILITY PROCEDURE AND INGESTED SMARTPILL CAPSULE. 24 TO 30 HOURS AFTER INGESTION PT WENT TO EMERGENCY ROOM COMPLAINING, HE HAD SOMETHING CAUGHT IN HIS THROAT. X-RAY SHOWED FOREIGN BODY, IDENTIFIED BY RADIOLOGIST AS "A LIGHT BULB-LIKE OBJECT" IN THE LOWER ESOPHAGUS ABOVE THE LES. EGD PERFORMED AND FOREIGN BODY REMOVED. PT DISCHARGED. PT'S PRIVATE PHYSICIAN IDENTIFIED OBJECT AS SMARTPILL CAPSULE. PT SEEN BY HIS PHYSICIAN - NO FURTHER ISSUES DUE TO EGD, RETAINED FOREIGN OBJECT, OR OBJECT REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPILL GI MONITORING SYSTEM GASTROINTESTINAL MOTILITY CAPSULE NYV THE SMARTPILL CORPORATION PH.P CAPSULE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention