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 further action to be taken unless the patient responds with more information.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 could not be reviewed as the lot number was not provided.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.The company cannot verify the report and was unable to conduct further investigation due to the limited information that was provided in the post.Out of an abundance of caution and a desire for strict compliance, the company is reporting the limited information that was provided.
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Complainant stated in a social media post ," i had issues the entirety of when my band was in place.It was removed and left an inch and half hole in my stomach where it was.I ended up septic, bleeding out internally, and multi organ failure, in a coma, fighting for my life".No other relevant information was provided.
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