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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC ORBERA INTRAGASTRIC BALLOON SYSTEM

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APOLLO ENDOSURGERY, INC ORBERA INTRAGASTRIC BALLOON SYSTEM Back to Search Results
Model Number B-50000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Flatus (1865)
Event Date 02/02/2018
Event Type  Injury  
Manufacturer Narrative
The physician indicated the device was discarded.A review of the device labeling notes: precautions and warnings: the physiological response of the patient to the presence of orbera® 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, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Patients need to be evaluated and the device removed at or within 6 months of placement.Adverse events: it is important to discuss all possible complications and adverse events with your patient.Complications that may result from the use of this product include the risks associated with the medications and methods utilized in the endoscopic procedure, the risks associated with any endoscopic procedure, the risks associated with the orbera intragastric balloon specifically, and the risks associated with the patient's degree of intolerance to a foreign object placed in the stomach.Possible complications - possible complications of the use of orbera® include: - gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.
 
Event Description
Reported as: a patient with the orbera intragastric balloon had been "discharged but contacted the doctor that evening as unable to tolerate any fluids.Patient was diagnosed with pneumatosis and for patient safety was extracted.Extraction was successful and patient recovered although very disappointed as wanted the orbera to remain insitu but followed the doctor recommendation for early extraction to prevent [dic] condition from deteriorating.".
 
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Brand Name
ORBERA INTRAGASTRIC BALLOON SYSTEM
Type of Device
INTRAGASTRIC BALLOON
Manufacturer (Section D)
APOLLO ENDOSURGERY, INC
1120 s. capital of texas hwy
bldg. 1, ste. 300
austin TX 78746
Manufacturer (Section G)
APOLLO ENDOSURGERY COSTA RICA, SRL
coyol free zone
building b 13.3
alajuela, costa rica
CS  
Manufacturer Contact
laura lebouef
1120 s. capital of texas hwy
bldg. 1, ste. 300
austin, TX 78746
5122795141
MDR Report Key7317855
MDR Text Key101655173
Report Number3006722112-2018-00084
Device Sequence Number1
Product Code LTI
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P140008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 02/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date07/26/2019
Device Model NumberB-50000
Device Catalogue NumberB-50000
Device Lot NumberAF01051
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/05/2018
Initial Date FDA Received03/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age37 YR
Patient Weight88
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