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 2020-03-19 for SOLYX SIS SYSTEM M0068507000 850-700 manufactured by Boston Scientific Corporation.
[184061960]
(b)(4). The complainant indicated that the device remains implanted and will not be returned for evaluation; 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
[184061961]
It was reported to boston scientific corporation that a solyx sis system was implanted into the patient for the treatment of uterine prolapse, cystocele, rectocele, and stress urinary incontinence (sui) during a procedure performed on (b)(6) 2010. As reported by the patient's attorney, the patient underwent a revision procedure of the solyx device on (b)(6) 2016 due to bladder neck obstruction. Boston scientific has been unable to obtain additional information regarding the event to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00995 |
| MDR Report Key | 9852824 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2016-05-17 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2010-06-30 |
| Date Added to Maude | 2020-03-19 |
| 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 | FREUDENBERG MEDICAL MIS INC |
| Manufacturer Street | 2301 CENTENNIAL BOULEVARD |
| Manufacturer City | JEFFERSONVILLE IN 47130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47130 |
| 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 | 2020-03-19 |
| Model Number | M0068507000 |
| Catalog Number | 850-700 |
| Lot Number | 1ML0060903 |
| Device Expiration Date | 2013-06-30 |
| 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 | 2020-03-19 |