BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507000 |
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 01/23/2017 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a solyx sis system device was implanted into the patient during the solyx placement and cystoscopy procedure performed on (b)(6) 2017 for the treatment of urinary incontinence.Reportedly, the patient tolerated the procedure well and transferred to the recovery room in stable condition.As reported by the patient's attorney, the patient has experienced an unspecified injury.
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Manufacturer Narrative
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Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2017 was chosen as a best estimate based on the date of the mesh was implanted.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.
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Search Alerts/Recalls
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