OBALON BALLOON SYSTEM 7600-0001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-11 for OBALON BALLOON SYSTEM 7600-0001 manufactured by Obalon Therapeutics, Inc..

MAUDE Entry Details

Report Number3009256831-2020-00001
MDR Report Key9696626
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-11
Date of Report2020-01-13
Date of Event2020-01-11
Date Mfgr Received2020-01-13
Device Manufacturer Date2017-11-22
Date Added to Maude2020-02-11
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 ContactMS. AMY VANDENBERG
Manufacturer Street5421 AVENDIA ENCINAS SUITE F
Manufacturer CityCARLSBAD, CA
Manufacturer CountryUS
Manufacturer Phone7956551
Manufacturer G1OBALON THERAPEUTICS, INC.
Manufacturer Street5421 AVENIDA ENCINAS SUITE F
Manufacturer CityCARLSBAD, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOBALON BALLOON SYSTEM
Generic NameINTRAGASTIC BALLOON
Product CodeLTI
Date Received2020-02-11
Model Number7600-0001
Lot Number171122406
Device Expiration Date2018-11-21
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOBALON THERAPEUTICS, INC.
Manufacturer Address5421 AVENDIA ENCINAS SUITE F CARLSBAD, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-02-11

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