InjuryPGD
PILLCAM
Received Oct 8, 2019 · Event occurred Sep 10, 2019
Report 9710107-2019-00446 · MDR key 9166106
Device
Generic name
Colon Capsule Imaging System
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0517Catalog number
FGS-0517
Lot number
46735C
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
51 YR
- Dehydration
- Vomiting
- Dehydration
- Vomiting
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, THE PATIENT FELT THAT THEY WERE DEHYDRATED AND VOMITED. THE PATIENT DECIDED TO GO TO THE EMERGENCY ROOM AND WAS TREATED WITH IV (INTRAVENOUS) FLUIDS AND WITH A MEDICATION PRAMIN. THE PATIENT WAS DISCHARGED AFTER 4 HOURS IN GOOD GENERAL CONDITION. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS NOT UNDER ANESTHESIA. A REPEAT PROCEDURE WAS NOT NECESSARY.