Initially this event was reported to a boston scientific (bsc) sales rep on (b)(6) 2015 with the following: the pt had coaptite bulking injection.Immediately post procedure, the patient was noted to be very sick, had an episode of vomiting, unreported diabetes and got sepsis.No treatment info was provided.On (b)(6) 2015, bsc noted that the date of injection was (b)(6) 2015.On (b)(6) 2015, the bsc sales rep noted that 2 separate coaptite syringes were used with a sidekick needle during the procedure.The injecting physician was contacted by boston scientific and on (b)(6) 2015 updated/further info was provided.The day of the procedure was (b)(6) 2015.The physician reported that several weeks ago she did a coaptite injection (1 syringe full) on a woman she had been following for mixed incontinence and prolapse.She had removed the pt's pessary a month before the injection.At that time the doctor had noted the pt had glycosuria of > 2000.He ordered a hgba1c and glucose on the pt and suggested she see her primary.The hgba1c was 14.The pt did not see her primary doctor.Post coaptite procedure, the pt was able to void before leaving office.After the pt left the office she immediately started vomiting and had chills.The pt went to the er.She was afebrile, had blood in her urine, an elevated white count with a bandemia and a glucose of >500.She was admitted and her diabetes was treated.Per dr.(b)(6), all cultures were negative through she does not know if a urine culture was obtained.At er - hematuria identified; (noted, common cause from coaptite injection).A uti ct scan was performed on the pt's abdomen.The pt has subsequently been discharged.She has followed up dr.(b)(6) at the end of last week.She had no glycosuria and her urine was clear.She still has some urge leakage but no sui.There is no evidence of any periurethral swelling, pain or tenderness which is what one would expect if the coaptite was infected, either primarily or by injection while the pt had bacteriuria.
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