BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLIICAM SB2 CAPSULE

    MDR report key: 4543391 · Received November 6, 2014

    Report

    Report Number
    9710107-2014-00233
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    November 6, 2014
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K101250
    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.

    Description of Event or Problem · 1

    A (B)(6) MAN WITH ANEMIA WAS REFERRED TO HOSP TO UNDERGO CAPSULE ENDOSCOPY (CE), WHICH REVEALED SMALL INTESTINAL ULCERS. FIVE MONTHS AFTER CE, HE RETURNED BECAUSE OF RECURRENT ANEMIA WITHOUT ABDOMINAL SYMPTOMS. ABDONIMAL X-RAY AND COMPUTED TOMOGRAPHY SHOWED CAPSULE RETENTION IN THE SMALL INTESTINE AT THE PELVIC CAVITY. THE CAPSULE REMAINED AT THE SAME PLACE FOR 7 DAYS. WE PERFORMED CAPSULE RETRIEVAL BY SPECTROSCOPY ASSISTED SURGERY WITH RESECTION OF THE INVOLVED SMALL INTESTINE, INCLUDING AN ILEA STRICTURE. RESEATED SPECIMEN SHOWED DOUBLE ULCERS WITH DIFFERENT MORPHOLOGIES, AN ULCER SCAR WITH STRICTURE, AND A WIDE ULCER AT THE PROXIMAL SIDE OF THE OTHERS. EACH ULCER HAD DIFFERENT HISTOPATHOLOGICAL FINDINGS SUCH AS THE DEGREE OF FIBROSIS AND MONOCYTE INFILTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716045 PLIICAM SB2 CAPSULE PLIICAM SB2 CAPSULE NEZ GIVEN IMAGING LTD. PLIICAM SB2 CAPSULE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention