It was reported to boston scientific corporation that a spaceoar vue device was implanted during a spaceoar vue placement procedure performed on october 20, 2022.Additionally, fiducial markers were placed.The patient fell and laid in his urine and feces for two days, and the patient was brought to the emergency room on (b)(6) 2022.The patient complained of pelvic pain, rectal pain, and difficulty urinating.Computerized tomography (ct) imaging was performed, and it was noticed that the patient has a pelvic abscess of 7.6 cm.The abscess was between the prostate gland and the rectum.The urinary bladder was distended.It was also noticed that there was sigmoid diverticulosis.The appendix was normal.Air from the soft tissue infiltrated the perineum and right gluteus.The soft tissue air was present at the base of the penis and extended to midshaft of the penis.The impression of the imaging indicated a pelvic abscess between the prostate gland and rectum and new air in the perineum at the base of the penis and right gluteus was consistent with necrotizing fasciitis.The patient was reported to be in the health care facility and had several incisions and drainages (i&d's) as well as a diverting colostomy.The physician believed the event was a complication from the procedure.Boston scientific corporation has been unable to obtain additional details, despite good faith efforts (gfes).
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