It was reported by the patient that the lap band broke.Per report, the patient received the gastric band in 2005.In 2012, the gastric band broke and the it has not been taken out due to financial difficulty.The patient's treating physician stopped practicing so the patient would need to find a new surgeon.The patient complaint of having so much reflux and random vomiting.The patient constnatly feel like something stuck in the throat and swallowing feels weird at time.The patient also claimed the port site is painful.No additonal information was provided.
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Attempts to contact the patient for additional information were made; however, there has been no response from the patient.No information available regarding the product that was involved.Multiple attempts to obtain additional information for an investigation were unsuccessful.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.Section date of event and implant date, only the year was provided.
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