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 2020-02-12 for REUSABLE ELECTRODE, 10CM, NITINOL NE-RF-10 manufactured by Neurotherm, Inc.
Report Number | 3004617090-2020-00001 |
MDR Report Key | 9703336 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2020-02-12 |
Date of Report | 2020-02-12 |
Date of Event | 2020-01-28 |
Date Mfgr Received | 2020-01-29 |
Date Added to Maude | 2020-02-12 |
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 | STEPHANIE O' SULLIVAN |
Manufacturer Street | 5050 NATHAN LANE NORTH |
Manufacturer City | PLYMOUTH MN 55442 |
Manufacturer Country | US |
Manufacturer Postal | 55442 |
Manufacturer Phone | 6517565400 |
Manufacturer G1 | NEUROTHERM, INC |
Manufacturer Street | 600 RESEARCH DRIVE STE 1 |
Manufacturer City | WILMINGTON MA 01887 |
Manufacturer Country | US |
Manufacturer Postal Code | 01887 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | REUSABLE ELECTRODE, 10CM, NITINOL |
Generic Name | PROBE, RADIOFREQUENCY LESION |
Product Code | GXD |
Date Received | 2020-02-12 |
Returned To Mfg | 2020-02-06 |
Model Number | NE-RF-10 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | NEUROTHERM, INC |
Manufacturer Address | 600 RESEARCH DRIVE STE 1 WILMINGTON MA 01887 US 01887 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-02-12 |