ORBERA365? INTRAGASTRIC BALLOON SYSTEM B-50012

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 2020-02-03 for ORBERA365? INTRAGASTRIC BALLOON SYSTEM B-50012 manufactured by Apollo Endosurgery, Inc..

Event Text Entries

[186735237] Initial medwatch submitted to the fda. The reporter of the event was asked to return the product for analysis. To date, apollo has not received the device. A review of the device labeling notes the following: the current orbera365? Intragastric balloon system directions for use (dfu) addresses the known and anticipated potential event of "deflation" as follows: warnings and precautions: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) may be higher when balloons are left in place longer than 12 months or used at larger volumes (greater than 700 cc). The physiological response of the patient to the presence of the orbera365? System balloon may vary depending upon the patient's general condition and the level and type of activity. The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response. Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications. Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, acute pancreatitis, spontaneous inflation, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms. Complications- possible complications of the use of the orbera365? System include: balloon deflation and subsequent replacement.
Patient Sequence No: 1, Text Type: N, H10


[186735238] Reported as: "the patient didn't feel satiety and urinated methylene blue. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006722112-2020-00014
MDR Report Key9660852
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-03
Date of Report2020-01-21
Date of Event2020-01-07
Date Mfgr Received2020-01-21
Device Manufacturer Date2018-06-11
Date Added to Maude2020-02-03
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 78746
Manufacturer CountryUS
Manufacturer Postal78746
Manufacturer G1APOLLO ENDOSURGERY COSTA RICA, SRL
Manufacturer StreetCOYOL FREE ZONE BUILDING B 13.3
Manufacturer CityALAJUELA,
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameORBERA365? INTRAGASTRIC BALLOON SYSTEM
Generic NameINTRAGASTRIC BALLOON
Product CodeLTI
Date Received2020-02-03
Model NumberB-50012
Catalog NumberB-50012
Lot NumberAF01965
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 78746 US 78746


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.