PILLCAM FGS-0391

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-02 for PILLCAM FGS-0391 manufactured by Given Imaging Ltd., Yoqneam.

Event Text Entries

[177235256] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[177235257] According to the reporter, the capsule was retained. There was no reported patient outcome.
Patient Sequence No: 1, Text Type: D, B5


[182654331] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[182654332] According to the reporter, the capsule was retained. They checked the capsule location with an abdominal x-ray which showed the capsule was still retained in the small bowel and the capsule has not been removed surgically. The patient reported that they can feel the capsule in the lower abdominal umbilical area. The patient had a stricture and they need to ensure that the patient had a patency capsule first.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710107-2020-00005
MDR Report Key9540358
Report SourceFOREIGN,USER FACILITY
Date Received2020-01-02
Date of Report2020-02-19
Date of Event2019-12-17
Date Mfgr Received2020-02-04
Date Added to Maude2020-01-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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, GASTROINTESTINAL, WIRELESS, CAPSULE
Product CodeNEZ
Date Received2020-01-02
Model NumberFGS-0391
Catalog NumberFGS-0391
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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. Required No Informationntervention 2020-01-02

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