Medwatch sent to fda on: 10/20/2015.The reporter of the complaint was asked to return the product for analysis.The device has not yet been received by allergan.Allergan has not received the product at this time.Therefore no analysis or testing has been done.Malaise and unsatisfactory weight loss are surgical/physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.No additional information has been reported to allergan regarding the serial number, the event date, implant date, treatment date, explant date, diagnostic testing, patient data or further event details.Device labeling addresses the reported event of malaise as follows: the physiological response of the patient to the presence of the orbera¿ system balloon may vary depending upon the patient¿s general conduction 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.Device labeling addresses the reported event of insufficient weight loss as follows: complications possible complications of the use of the orbera¿ system include: insufficient or no weight loss.
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