BRAVO FGS-0313

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-0313 manufactured by Given Imaging Ltd., Yoqneam.

Event Text Entries

[185899795] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185899796] According to the reporter, the capsule failed to transmit. Technical support had the customer use a second recorder, but the capsule was not detected by the customer either. They used a second capsule, and it was detected. There was no patient or user harm.
Patient Sequence No: 1, Text Type: D, B5


[189068559] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9710107-2020-00182
MDR Report Key9908821
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-0313
Catalog NumberFGS-0313
Lot Number48064Q
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
10 2020-03-31

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