It was reported by the patient that the patient developed seroma and experienced dehydration while having lap band.Per report, the patient received the gastric band in 2016.The patient lost 80 lbs prior receiving the gastric band and gained 60 lbs back after.According to the patient, the patient could not "get fluids through due to hormonal fluctuations" during the menstrual cycle.The patient was in the er twice to receive iv fluids due to dehydration.The patient decided to have a mini bypass and had the band system removed from the abdominal cavity; however, the port and the tubing were left under the skin, which developed a seroma.There was scaring noted per the report.The patient met with a surgeon and had the tubing and seroma removed, but the port was not removed.Later on the surgery day, the patient was admitted into er due to excessive bleeding.The bleeding was stopped with an abdominal binder while the patient's husband drove the patient to another hospital.The patient received iv fluids and pain medication before being sent home.Over the next several days, the staples got loose and the wound was open.The patient "had to pack with gauze" twice a day until it healed.
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Attempts to contact the patient for additional information were made; however, there was no response from the patient.No investigation was performed.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 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.Only the year was provided by the patient.
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