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 Problems
Incontinence (1928); Pain (1994); Constipation (3274); Dyspareunia (4505)
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Event Date 05/18/2017 |
Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that a solyx implant was implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: anal pain; painful intercourse; difficulties with bowel motions; incontinence not present before implant.Surgical interventions: on (b)(6) 2017 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: colonoscopy and endoscopy.On (b)(6) 2018 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: colonoscopy.On (b)(6) 2021 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: colonoscopy.On (b)(6) 2017 the patient underwent further surgery regarding the solyx implant under general anesthesia for the following purpose: colonoscopy and endoscopy.
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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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Search Alerts/Recalls
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