BOSTON SCIENTIFIC - MARLBOROUGH 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
Erosion (1750)
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Event Date 03/29/2017 |
Event Type
Injury
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Manufacturer Narrative
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The complainant indicated that the device is implanted and will not 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 solyx sis system was implanted during a solyx placement procedure performed on (b)(6) 2014.According to the complainant, on march 29, 2017, the patient presented with vaginal mesh exposure of 2mm away from area of suture line.The mesh was trimmed and ovestin pv cream was prescribed.The patient is recovering.
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Search Alerts/Recalls
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