MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-08-06 for SYMPHION FG-0201 74080 manufactured by Boston Scientific Corporation.
| Report Number | 3005099803-2019-03974 |
| MDR Report Key | 8865455 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-08-06 |
| Date of Report | 2019-08-06 |
| Date of Event | 2019-06-18 |
| Date Mfgr Received | 2019-07-22 |
| Date Added to Maude | 2019-08-06 |
| 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 017521242 |
| Manufacturer Country | US |
| Manufacturer Postal | 017521242 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | SMC COSTA RICA |
| Manufacturer Street | EDIFICIO B48 AVENIDA 0 , |
| Manufacturer City | ZONA FRANCA COYOL, ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMPHION |
| Generic Name | INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA |
| Product Code | PGT |
| Date Received | 2019-08-06 |
| Model Number | FG-0201 |
| Catalog Number | 74080 |
| 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 017521242 US 017521242 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2019-08-06 |