Event date: the exact date of the event is unknown.The provided event date, (b)(6) 2022, was chosen as a best estimate based on the date that the manufacturer became aware of the event, (b)(6) 2022.The complainant was unable to provide the suspect device lot number.Therefore, the expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on an unknown date.After the spaceoar placement procedure, the ejaculatory duct was damaged by the needle during placement.A small amount of the spaceoar gel came out of the urethra via the seminal vesicles.Hematuria occurred again and subsided within 1 day.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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