P/CAM PATENCY CAPL 1-PK
Received Nov 17, 2015
Report 9710107-2015-05036 · MDR key 5230969
Device
Generic name
System, Imaging, Esophageal, Wireless, Capsule
Manufacturer
Given Ltd (israel)Model number
FGS-0109Catalog number
FGS-0109
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Abdominal Pain
Narrative
Additional Manufacturer Narrative
(B)(4).
Additional Manufacturer Narrative
(B)(4) INITIAL REPORT DATE: 11/17/2015. TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem
CUSTOMER REPORTED PATIENT EXPERIENCING ABDOMINAL PAIN AFTER TAKING PATENCY CAPSULE. PHYSICIAN IS NOT CERTAIN IF THE CAPSULE HAS PASSED. PHYSICIAN PLANS TO CONDUCT A CT SCAN TO DETERMINE IF THE PATENCY CAPSULE IS RESIDING IN THE DESCENDING COLON. PREVIOUS CT SCANS WERE NORMAL SHOWING NO STRICTURES. THIS IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.