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 02/14/2024 |
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.Block h4: the complainant was unable to provide the suspect 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 an unspecified injury.Imdrf impact code f12 has been used in the light of the patient seeking legal recourse for an unspecified personal injury related to the device.
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Search Alerts/Recalls
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