Multiple attempts to contact the doctor for additional information were made; however, there has been no response from the doctor.No information is available regarding the product that was involved.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 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.
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Patient stated on social media that their lap-band caused acid reflux and vomiting and started to be rejected by her body after 3 to 5 years post implant.After contacting patient for additional information, she reported back pain, groin pain, stomach pain, severe gerd and nose bleeds.She also stated nighttime fluid coming through her nose, sometimes causing choking.She stated the device was removed after a visit to the emergency room.
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