Apollo has not received the product at this time.Therefore no analysis or testing has been done.Additional information regarding this late medwatch report: during a (b)(6) 2019 internal review of post-market surveillance data for all apollo products, apollo executive management was made aware that complaints associated with the ce marked orbera365 (12-month intragastric balloon) were not being assessed for reportability consistent with the requirements of 21 cfr 803.Consideration for reportability in the us was incorrectly established based on the difference in the indications for use (i.E.12-month placement vs 6-month placement) vs considerations for 'similar devices' marketed by apollo.The orbera365 12-month intragastric balloon is a [?]similar device' as compared to the orbera 6-month balloon approved via pma p140008, and as such, complaints will be assessed for mdr reportability going forward.A review of the device labeling notes the following: warnings and precautions: the risk of balloon deflation and intestinal obstruction (and therefore possible death related to intestinal obstruction) may be higher when balloons are left in place longer than 12 months or used at larger volumes (greater than 700 cc).The physiological response of the patient to the presence of the orbera365¿ 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, acute pancreatitis, spontaneous inflation, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms.Complications- possible complications of the use of the orbera365¿ system include: balloon deflation and subsequent replacement.
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