BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Catalog Number 73020 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 12/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).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 single incision sling was implanted during a procedure performed in 2017.According to the complainant, after the procedure, the patient has been experiencing reactions due to the implant material.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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