FDA Adverse Event
Injury
Summary report: N
SOLYX SIS SYSTEM
MDR report key: 3192643
·
Received June 27, 2013
Report
- Report Number
- 3005099803-2013-05263
- Event Type
- Injury
- Date Received
- June 27, 2013
- Report Date
- June 6, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081275
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS IMPLANTED (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS LAST SEEN IN (B)(4) 2011 AND WAS STILL EXPERIENCING URINARY LEAKAGE. THE PATIENT WAS TREATED WITH MEDICATION FOR AN OVERACTIVE BLADDER. THE TYPE AND DOSAGE ARE UNKNOWN. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292583 | SOLYX SIS SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | UNK660 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |