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 2018-11-01 for SYMPHION FG-0202 74052 manufactured by Boston Scientific Corporation.
[125910094]
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[125910095]
It was reported to boston scientific corporation on (b)(6) 2018 that a symphion fluid management accessory was checked during an inventory on (b)(6) 2018. According to the complainant, during inventory, the symphion fluid management accessory was pulled out from the shelf and it was noted that the clear sterile package of the device had a crack on the right corner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-61169 |
| MDR Report Key | 8030486 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-01 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-09 |
| Date Mfgr Received | 2018-10-09 |
| Date Added to Maude | 2018-11-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 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 | 2018-11-01 |
| Model Number | FG-0202 |
| Catalog Number | 74052 |
| 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 | 2018-11-01 |