PILLCAM FGS-0109

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-28 for PILLCAM FGS-0109 manufactured by Given Imaging Ltd., Yoqneam.

MAUDE Entry Details

• Report Number: 9710107-2019-00298
• MDR Report Key: 8746659
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-06-28
• Date of Report: 2019-06-28
• Date of Event: 2019-03-27
• Date Mfgr Received: 2019-06-10
• Device Manufacturer Date: 2019-03-04
• Date Added to Maude: 2019-06-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: AMY BEEMAN
• Manufacturer Street: 161 CHESHIRE LANE, SUITE 100
• Manufacturer City: PLYMOUTH MN 55441
• Manufacturer Country: US
• Manufacturer Postal: 55441
• Manufacturer Phone: 7632104064
• Manufacturer G1: GIVEN IMAGING LTD., YOQNEAM
• Manufacturer Street: YETSIRA 13 STREET
• Manufacturer City: YOQNEAM 20692
• Manufacturer Postal Code: 20692
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PILLCAM
• Generic Name: SYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE
• Product Code: NSI
• Date Received: 2019-06-28
• Model Number: FGS-0109
• Catalog Number: FGS-0109
• Lot Number: 45103
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GIVEN IMAGING LTD., YOQNEAM
• Manufacturer Address: YETSIRA 13 STREET YOQNEAM 20692 20692

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2019-06-28