Attempts to contact the patient for additional information were made; however, no response was received from the patient.No information available regarding the product that was involved.The patient did not provide information for an investigation.Unable to determine if the complaint is about the lap-band or about another band which was available in the us and phased out at the end of 2016.Unable to determine root cause or conduct trending analysis.No new risks identified, the current risk is identified with a low rate of occurrence for the reported complaint categories.No correction or corrective action required.The lot history record for the complaint was not available for review.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.If additional information would be available for investigation in the future, a supplemental report would be made.At this time, the reported issue will be tracked and trended.For the event date, only the year was provided.
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It was reported by the patient that the lap band moved up around the patient's esophagus.Per report, the patient experienced very bad acid reflux since 2016.Sometimes, the reflux was bad that it came through patient's nose.The patient could not sleep at night due to reflux.The patient has gained weight back.No information was provided on whether if the patient still has the gastric band or if intervention was required.
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