BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 2707303 · Received August 15, 2012

    Report

    Report Number
    9710107-2012-01538
    Event Type
    Injury
    Date Received
    August 15, 2012
    Report Date
    August 15, 2012
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K070475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    GIVEN IMAGING LABELING, SUCH AS USER MANUAL INDICATE THAT PILLCAM SB CAPSULES ARE CONTRAINDICATED FOR USE IN PTS WITH KNOWN OR SUSPECTED GASTROINTESTINAL OBSTRUCTION, STRICTURES, OR FISTULAS BASED ON THE CLINICAL PICTURE OR PRE PROCEDURE TESTING AND PROFILE. DIAGNOSTIC TOOLS ARE AVAILABLE TO PHYSICIANS TO ASSESS PTS BEFORE ADMINISTRATION OF THE PILLCAM SB CAPSULE INCLUDING THE AGILE PATENCY SYSTEM, CT ENTEROGRAPHY, OR MR ENTEROGRAPHY. ALTHOUGH THE PTS HAD NO KNOWN HISTORY OF SWALLOWING PROBLEMS AND THE CAPSULE INGESTION WAS UNEVENTFUL, ONE MAY SUSPECT, HOWEVER, THAT THE PT DOES INDEED HAVE A SWALLOWING PROBLEM IF HE DID ASPIRATE THE CAPSULE WITHOUT ANY GAGGING OR CONTINUOUS COUGHING. SWALLOWING DISORDER IS A RECOGNIZED CONTRAINDICATION TO THE USE OF CAPSULE ENDOSCOPY. THE ARTICLE WAS PUBLISHED AS: CONCINI M., RARE COMPLICATION DURING VIDEO-CAPSULE ENDOSCOPY, DIGESTIVE ENDOSCOPY, JAPAN GASTROENTEROLOGICAL ENDOSCOPY SOCIETY, 2012, 24:280.

    Description of Event or Problem · 1

    A PUBLICATION REGARDING A CASE OF CAPSULE ASPIRATION. AN (B)(6) PT, GASTRECTOMIZED FOR CANCER, WAS REFERRED TO CAPSULE ENDOSCOPY INVESTIGATION OF OGIB. IMMEDIATELY AFTER SWALLOWING THE CAPSULE, HE COUGHED A FEW TIMES, BUT HAD NO FURTHER SYMPTOMS AND CONTINUED THE EXAMINATION. ON VIEWING THE FILM, THE PT WAS QUESTIONED AND SAID THAT IN THE PAST HE HAD SOMETIMES COUGHED WHEN HE SWALLOWED A TABLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLCAM SB2 CAPSULE PILLCAM SB CAPSULE NEZ GIVEN IMAGING LTD. PILLCAM SB2 CAPSULE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R