The reporter of the event was asked to return the product for analysis, and to indicate product serial number.To date, neither the device nor any further device information has been received by apollo.Device labeling addresses the reported event as follows: precautions: 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.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.The event of hiatal hernia was reported in the us pivotal clinical study and was experienced by less than.5% of the participants.
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