PILLCAM FGS-0391

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-04 for PILLCAM FGS-0391 manufactured by Given Imaging Ltd., Yoqneam.

MAUDE Entry Details

• Report Number: 9710107-2019-00528
• MDR Report Key: 9273472
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2019-11-04
• Date of Report: 2019-11-17
• Date of Event: 2019-10-18
• Date Mfgr Received: 2019-10-31
• Device Manufacturer Date: 2019-01-03
• Date Added to Maude: 2019-11-04
• 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, GASTROINTESTINAL, WIRELESS, CAPSULE
• Product Code: NEZ
• Date Received: 2019-11-04
• Model Number: FGS-0391
• Catalog Number: FGS-0391
• Lot Number: 44226U
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• 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. Required No Informationntervention	2019-11-04