(b)(4).Additional information was requested and the following was obtained: we are attempting to determine why the band was removed initially.Was the patient experiencing problems? yes, chronic pain at the port site, nausea, and lack of weight loss.Did the patient present with any symptoms? if so, what were they? pain at port site.Nausea.Surgical findings of extensive adhesions.Has it been determined /confirmed that the patient¿s symptoms are directly related to the realize band? temporally associated with the presence of the band, and the retained plastic tubing strain relief collar which had become loose.Was any test performed to diagnose the issue? fluoroscopy? endoscopy? culture? surgical removal of the band on the second surgery, and removal of the retained plastic tubing strain relief collar on the third surgery.What information did the testing provide? adhesions on the retained plastic tubing strain relief collar.
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