MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-18 for SOLYX SIS SYSTEM manufactured by Boston Scientific Corporation.
[189010914]
The complainant was unable to provide the upn and lot number of the suspect device. Therefore, the manufacture and expiration dates are unknown. (b)(4). The device has not been received for analysis; 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.
Patient Sequence No: 1, Text Type: N, H10
[189010915]
It was reported to boston scientific corporation that the patient was implanted with a solyx sling on (b)(6) 2014. The associated post-operative diagnosis was cystocele, rectocele, stress incontinence, recurrent urinary tract infections. As reported by the patient's attorney, the patient underwent a revision surgery related to the solyx device on (b)(6) 2017. The associated post-operative diagnosis was mesh erosion into the left bladder neck, stress urinary incontinence, dyspareunia, hematuria, recurrent urinary tract infections, pelvic pain. Boston scintific has been unable to obtain additional information regarding the event to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-01172 |
| MDR Report Key | 9846550 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2017-05-31 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLYX SIS SYSTEM |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA |
| Product Code | PAH |
| Date Received | 2020-03-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |