Device labeling addresses the reported event as follows: the physiological response of the patient to the presence of the orbera 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, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such.Complications: possible complications of the use of the orbera system include: - gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon.- continuing nausea and vomiting.This could result from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach.It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus.- abdominal and back pain; either steady or cyclic.
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Supplement #1 - medwatch sent to fda on 18-may-2018.Device evaluation summary: the device was returned to apollo for analysis, and visual examination noted the balloon shell to be discolored, as it was light blue and brown in appearance.White particles were noted on the outer surface of the balloon shell, and blue particles were observed on the inner surface of the balloon shell.A sample fill tube was used for device testing.A valve test was performed, and when di water was injected into the valve, the flow of fluid was continuous and unobstructed.An air leak test was performed, and leakage was noted from three openings on the radius of the shell.Under microscopic analysis, all of the openings were noted to have striated edges, consistent with surgical damage and device removal activities.The inner surface of the valve channel was noted to be discolored, as it was blue in appearance.Brown particles were observed in the valve channel.
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