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 Number9710107-2019-00298
MDR Report Key8746659
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-06-28
Date of Report2019-06-28
Date of Event2019-03-27
Date Mfgr Received2019-06-10
Device Manufacturer Date2019-03-04
Date Added to Maude2019-06-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAMY BEEMAN
Manufacturer Street161 CHESHIRE LANE, SUITE 100
Manufacturer CityPLYMOUTH MN 55441
Manufacturer CountryUS
Manufacturer Postal55441
Manufacturer Phone7632104064
Manufacturer G1GIVEN IMAGING LTD., YOQNEAM
Manufacturer StreetYETSIRA 13 STREET
Manufacturer CityYOQNEAM 20692
Manufacturer Postal Code20692
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePILLCAM
Generic NameSYSTEM, IMAGING, ESOPHAGEAL, WIRELESS, CAPSULE
Product CodeNSI
Date Received2019-06-28
Model NumberFGS-0109
Catalog NumberFGS-0109
Lot Number45103
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGIVEN IMAGING LTD., YOQNEAM
Manufacturer AddressYETSIRA 13 STREET YOQNEAM 20692 20692


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-06-28

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