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
Insufficient Information (4580)
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Event Date 02/09/2024 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a boston scientific mesh was implanted into the patient during a procedure performed on an unknown date.As reported by the patient's attorney, the patient has experienced an unspecified injury.Additional details regarding this event were not provided.
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Manufacturer Narrative
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Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspected device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf patient code e2401 captures the reportable event of unspecified injury related to mesh.Imdrf impact code f12 has been used in the light of the patient had filed a legal claim for an unspecified personal injury related to the device.
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Search Alerts/Recalls
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