BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507010 |
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 10/07/2020 |
Event Type
Injury
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Manufacturer Narrative
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Age at time of event: it was reported that the patient is approximately (b)(6) years old.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device is implanted and 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 a solyx blue sis system device was implanted into the patient during a (non-bsc) sling removal and reimplantation procedure performed on (b)(6) 2020 to treat incontinence.According to the complainant, during the patient's follow-up examination, the physician noticed two 1cm exposures on either side of the patient's incision.The patient is reportedly continent and asymptomatic.The issue is ongoing and the patient is considering different options for resolution including using a graft to cover the exposures.Boston scientific has been unable to obtain additional information regarding the patient's treatment progress to date, despite good faith efforts.
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Search Alerts/Recalls
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