Medwatch sent to fda on: 11/25/2015 no additional information has been reported to allergan regarding the model number, serial number, the event date, implant date, explant date, diagnostic testing, patient data or further event details.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.Device labeling addresses the reported event of pain as follows: possible complications of the use of the orbera system include: abdominal or back pain, either steady or cyclic.Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach.This could lead to ulcer formation with pain, bleeding or even perforation.Surgery could be necessary to correct this condition.
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