BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068505000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Code Available (3191)
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Event Date 12/31/2018 |
Event Type
Injury
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Manufacturer Narrative
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This event was reported by the patient's legal representation.The surgeon is: (b)(6).The patient had a revision surgery at: (b)(6).(b)(4).The removed mesh 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 an obtryx system - halo device was implanted into the patient during a procedure performed on (b)(6) 2011.As reported by the patient's attorney, the patient had a revision surgery at a different healthcare facility on (b)(6) 2018 and had a mesh removal surgery on (b)(6) 2020.Boston scientific has been unable to obtain additional information regarding the event to date.
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