It was reported by the patient that the lap band eroded into the patient's stomach.In 2015, the gastric band was found to erode into patient's stomach.The patient was throwing up bile, blood in stool and passed out.The gastric band was surgically removed due to emergency in 2015.
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Attempts to contact the physician for additional information were made; however, no response was received from the physician.No information available regarding the product that was involved.The physician 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.The patient provided 2 different implant dates, which will need to be verified by physician for the correct date.
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