BOSTON SCIENTIFIC CORPORATION; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 02/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event was approximated to (b)(6) 2020, the date the bsc was first made aware of the event, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).(b)(4) is being used in lieu of an adequate conclusion code for device not returned.The bladder sling is not expected to be returned for evaluation; therefore, a failure 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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Event Description
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It was reported to boston scientific corporation that a boston scientific bladder sling was implanted into the patient during a procedure.As per reported, after the procedure, the patient experienced allergic reactions.Boston scientific has been unable to obtain additional information regarding the event to date.
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Search Alerts/Recalls
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