BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 2431198 · Received January 24, 2012

    Report

    Report Number
    9710107-2012-00111
    Event Type
    Injury
    Date Received
    January 24, 2012
    Report Date
    February 14, 2012
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    FFT
    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 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.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED AT (B)(6). PT WITH A HISTORY OF CROHN'S DISEASE WHO PRESENTED WITH ACUTE ABDOMINAL PAIN WITH NAUSEA AND VOMITING FOUR DAYS AFTER INGESTION OF A PILLCAM SB CAPSULE. TWO DAYS PRIOR TO PRESENTATION, AN ABDOMINAL RADIOGRAPH REVEALED A CAPSULE IN THE PELVIC AREA. ON EXAMINATION, SHE APPEARED UNWELL WITH DEHYDRATION, TACHYCARDIA AND DIFFUSE ABDOMINAL SIGNS SUGGESTING PERITONITIS. FOLLOWING HER INITIAL RESUSCITATION, SHE WAS TAKEN FOR A LAPAROTOMY. FINDINGS REVEALED MULTIPLE SMALL BOWEL STRICTURES WITH PROXIMAL PERFORATION AND CAPSULE MIGRATION INTO THE FREE PERITONEAL CAVITY. PRESENCE OF SEVERE PERITONITIS WAS NOTED. THE DISEASED SMALL BOWEL SEGMENT, INCLUDING ALL THE STRICTURES AND THE PERFORATION SITE, WAS EXCISED EN BLOC AND A HIGH-END JEJUNOSTOMY WITH A MUCOUS FISTULA WAS FASHIONED. THE RESIDUAL SMALL BOWEL MEASURED 80CM OF PROXIMAL JEJUNUM AND 30CM OF TERMINAL ILEUM (NON-FUNCTIONAL). SIX MONTHS AFTER HER RESECTION, THE STOMA WAS REVERSED SUCCESSFULLY AND SHE IS NOT DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK FFT GIVEN IMAGING LTD. UNK NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R