Device Problem
Insufficient Information (3190)
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Patient Problem
Vomiting (2144)
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Event Type
Injury
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Manufacturer Narrative
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This information was posted on social media and attempts to contact the surgeon to follow-up or obtain additional information were unsuccessful and thus, 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, as is.No information is available regarding the product that was involved, the authenticity of the complainant, or the veracity of the information provided by the complainant.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 was not available to be reviewed.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 becomes available for investigation in the future, a supplemental report would be made.At this time, the reported issue will be tracked and trended.
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Event Description
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Complainant stated in a social media post, " i had it.I almost died.Had to get it emergency removed" "i had the lap band in 2010, never could have it filled because the port could never be accessed.About 5 years in, it got harder for me to eat or drink anything including water.I dropped 110 lbs in a month due to throwing up.When i went it to a different surgeon to help me, he had it immediately removed.Due to extensive damage from the band, he was not able to perform any other weight loss surgery.6 years later today, i have major digestive issues, often mimicking the lap band." no other relevant information was provided.
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Search Alerts/Recalls
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