BRAVO FGS-0636

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-31 for BRAVO FGS-0636 manufactured by Given Imaging Ltd., Yoqneam.

Event Text Entries

[185899621] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185899622] According to the reporter, they had a capsule which failed to attach. There was no harm to the patient and user harm and the capsule was removed with a roth net. There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal. No lubricant was used to facilitate placement of the capsule.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710107-2020-00181
MDR Report Key9908815
Report SourceUSER FACILITY
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-13
Date Mfgr Received2020-03-13
Date Added to Maude2020-03-31
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 CountryIL
Manufacturer Postal Code20692
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBRAVO
Generic NameELECTRODE, PH, STOMACH
Product CodeFFT
Date Received2020-03-31
Model NumberFGS-0636
Catalog NumberFGS-0636
Lot Number48088F
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 IL 20692


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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