BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
|
Back to Search Results |
|
Model Number 850-700 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Constipation (3274)
|
Event Date 07/02/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
It was reported to boston scientific corporation that a upsylon y-mesh implant and a solyx implant were implanted into the patient on (b)(6) 2016.The patient experienced complications and nonsurgical treatment.Patient symptoms include: back pain; pelvic pain; anal pain; off vag dis; diff bowel; rec incont; nonsurgical treatments: on (b)(6) 2017 the patient commenced pain medication: panadol, neurofen and voltarin for the treatment of: consistent lower back pain and pelvic pain.Treatment duration: 4 years.On (b)(6) 2021 the patient commenced other medication (please specify): jointq for the treatment of: lower back pain.Treatment duration: 28 days.On (b)(6) 2020 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: lower back and stomach pain.Treatment duration: 17 months.On (b)(6)2020 the patient commenced physiotherapy treatment (including pelvic floor exercises or training) for the treatment of: back and pelvic pain.Treatment duration: 15 months.
|
|
Search Alerts/Recalls
|
|
|