BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number 850-700 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Incontinence (1928); Pain (1994); Constipation (3274)
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Event Date 08/29/2018 |
Event Type
Injury
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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 into the patient on (b)(6) 2017.The patient experienced complications and further surgery.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; thigh pain; difficulties with bowel motions; recurrent incontinence.Surgical interventions: on (b)(6) 2018 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: hysterectomy and anterior vaginal compartment repair.
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Manufacturer Narrative
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Patient identifier: (b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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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Manufacturer Narrative
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Patient identifier: (b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The upn provided was chosen as a representative upn to capture the implanted device.The complainant indicated that the device is not available for return; 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 into the patient on (b)(6) 2017.The patient experienced complications and further surgery.Patient symptoms include: eep (erosion/extrusion/protrusion of the mesh); vaginal pain; pelvic pain; groin pain; anal pain; rectal pain; thigh pain; difficulties with bowel motions; recurrent incontinence.Surgical interventions: on (b)(6) 2018 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: hysterectomy and anterior vaginal compartment repair.
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Search Alerts/Recalls
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