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Patient 1
MEDWATCH SENT TO FDA ON: 11/13/2015. 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. VOMITING, PAIN, NAUSEA AND MALAISE 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, TREATMENT DATE, EXPLANT DATE, DIAGNOSTIC TESTING, PATIENT DATA OR FURTHER EVENT DETAILS. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF PAIN (DISCOMFORT), VOMITING AND NAUSEA AS FOLLOWS: 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. 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 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.