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
Incontinence (1928); Pain (1994); Constipation (3274); Insufficient Information (4580)
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Event Date 11/30/2016 |
Event Type
Injury
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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 an advantage and a solyx were implanted into the patient on (b)(6) 2016.The patient experienced complications, further surgery, and nonsurgical treatment.Patient symptoms include: pelvic pain; groin pain; thi pain; diff bowel; rec incont; aggrav incont; damage.Nonsurgical treatments: on (b)(6) 2016 the patient commenced pain medication: panadol/nurofen for the treatment of: pain treatment.Treatment duration: ongoing.On (b)(6) 2016 the patient commenced incontinence medication: vesicare + betmiga for the treatment of: treat incontinence.Treatment duration: ongoing.On (b)(6) 2016 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: help pelvic floor.On (b)(6) 2016 the patient commenced topical treatment (including oestrogen cream): oestrogen cream.Treatment duration: ongoing.On (b)(6) 2017 the patient commenced injections (not associated with surgical treatment): botox injections for the treatment of: to help with incontinence.Treatment duration: when required.
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