ORBERA? INTRAGASTRIC BALLOON SYSTEM B-50000

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 2020-03-09 for ORBERA? INTRAGASTRIC BALLOON SYSTEM B-50000 manufactured by Apollo Endosurgery, Inc..

MAUDE Entry Details

Report Number3006722112-2020-00040
MDR Report Key9808714
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-09
Date of Report2020-02-11
Date of Event2020-02-03
Date Mfgr Received2020-02-11
Device Manufacturer Date2019-02-13
Date Added to Maude2020-03-09
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 ContactDR. DAVID HOOPER
Manufacturer Street1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300
Manufacturer CityAUSTIN, TX
Manufacturer CountryUS
Manufacturer G1APOLLO ENDOSURGERY COSTA RICA, SRL
Manufacturer StreetCOYOL FREE ZONE BUILDING B 13.3
Manufacturer CityALAJUELA, CS
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameORBERA? INTRAGASTRIC BALLOON SYSTEM
Generic NameINTRAGASTRIC BALLOON
Product CodeLTI
Date Received2020-03-09
Model NumberB-50000
Catalog NumberB-50000
Lot NumberAF02518
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAPOLLO ENDOSURGERY, INC.
Manufacturer Address1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 AUSTIN, TX US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-09

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