PILLCAM
Received Nov 2, 2018
Report 9710107-2018-01022 · MDR key 8035216
Device
Generic name
System, Imaging, Esophageal, Wireless, Capsule
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0109Catalog number
FGS-0109
Product problems
- Entrapment of Device
- Entrapment of Device
Patient
Not reported
- Abdominal Pain
- Vomiting
- Abdominal Pain
- Vomiting
Narrative
Additional Manufacturer Narrative
TITLE DETECTION OF SMALL BOWEL MUCOSAL HEALING AND DEEP REMISSION IN PATIENTS WITH KNOWN SMALL BOWEL CROHN¿S DISEASE USING BIOMARKERS, CAPSULE ENDOSCOPY, AND IMAGING SOURCE THE AMERICAN JOURNAL OF GASTROENTEROLOGY, VOLUME 110, 2015(1316-1323) DATE OF PUBLICATION: 28 JULY 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, ONE PATIENT HAD A SYMPTOMATIC PATENCY CAPSULE RETENTION MANIFESTING WITH ABDOMINAL PAIN AND VOMITING. THE PATIENT WAS TREATED WITH CORTICOSTEROIDS WITH SUBSEQUENT RESOLUTION OF THE SYMPTOMS WITHIN 2 DAYS. ARTICLE: DETECTION OF SMALL BOWEL MUCOSAL HEALING AND DEEP REMISSION IN PATIENTS WITH KNOWN SMALL BOWEL CROHN¿S DISEASE USING BIOMARKERS, CAPSULE ENDOSCOPY, AND IMAGING AUTHOR: URI KOPYLOV , MD, YEAR: 2015 SEPTEMBER VOLUME110.