MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM PILLCAM; COLON CAPSULE IMAGING SYSTEM

Model Number	FGS-0517
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dehydration (1807); Vomiting (2144)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
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.

• Brand Name: PILLCAM
• Common Device Name: COLON CAPSULE IMAGING SYSTEM
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 9166106
• Report Number: 9710107-2019-00446
• Device Sequence Number: 17114818
• Product Code: PGD
• UDI-Device Identifier: 07290101364788
• UDI-Public: 07290101364788
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K153466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2020
• Device Model Number: FGS-0517
• Device Catalogue Number: FGS-0517
• Device Lot Number: 46735C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 60