BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB2 CAPSULE

    MDR report key: 2137358 · Received May 24, 2011

    Report

    Report Number
    9710107-2011-00425
    Event Type
    Injury
    Date Received
    May 24, 2011
    Report Date
    September 21, 2010
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON A PT WITH SEVERE (B)(6) DISEASE. THE PT HAD ONGOING GI COMPLAINTS WITHOUT A DIAGNOSIS BUT HAD A SUSPICIOUS CT SCAN. PT'S PHYSICIAN HAS ORDERED A CAPSULE ENDOSCOPY WHICH SHOWED SEVERE (B)(6) DISEASE ESPECIALLY IN THE TI. THE CAPSULE WAS RETAINED, THERE WERE SIGNS OF OBSTRUCTION, BUT THIS CLEARED AFTER STEROIDS WERE STARTED. ABOUT 6 DAYS LATER, AFTER BEING DISCHARGED HOME ON PREDNISONE, THE PT HAD ACUTE ONSET OF SEVERE PAIN, FEVER, TENDERNESS. A CT SHOWED NO OBSTRUCTION AND THE CAPSULE HAD MOVED DISTALLY BUT SEEMED TO BE AT THE TI. THE PT DID NOT IMPROVE ON ANTIBIOTICS, WENT ON TO SURGERY, AND HAD A LIMITED BOWEL RESECTION. THE SURGEON FOUND AN IMPACTED CAPSULE IN THE TI WITH AN ABSCESS, NO PERFORATION. THE PT LATER DEVELOPED SEPSIS, SHOCK, REQUIRED INTUBATION. BLOOD CULTURES GREW OUT KLEBSIELLA AND SHE HAS IMPROVED ON ANTIBIOTICS, IS EXTUBATED BUT STILL HOSPITALIZED.

    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 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R