Medwatch sent to fda on 02/04/2016.The reporter of the event was asked to return the product for analysis, as it was stated the device was scheduled for removal.To date, apollo has not received the device.This event was reported by the patient.To date, apollo has been unable to confirm the reported events with the patient's physician.Device labeling addresses the reported event as follows: warnings and precautions: 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 symptoms.Possible complications: possible complications of the use of orbera include: adverse health consequences resulting from weight loss.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.
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Reported as: the patient had the orbera intragastric balloon placed, and reported the following: "i'm closing the sixth month with the balloon and i had difficult times at the beginning and the middle of the treatment was calm.I had a dehydration and a urinary tract infection." the patient reported they are near the end of the sixth month placement period and are having the balloon removed soon, and are "now suffering again with constant vomiting.".
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