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 2020-03-17 for RF DISPOSABLE GROUNDING PAD manufactured by Neurotherm, Inc.
[187167705]
Investigation results will be provided in a subsequent submission. Further information was requested but not received.
Patient Sequence No: 1, Text Type: N, H10
[187167706]
One week following a radio frequency ablation (rfa), the patient returned to the surgery center with a burn on his leg from the grounding pad. During the procedure, the skin was not prepped and the grounding pad was placed on a hairy part of the leg for a cervical rfa. Attempts to ablate were unsuccessful. The grounding pad was noted to be too far away and was moved to the patients upper back to complete the procedure with no issues. The patient returned to the surgery center one week post procedure with 2nd degree burns on his leg. The generator has been used since without any issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002953813-2020-00011 |
| MDR Report Key | 9841902 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-17 |
| 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 | RF DISPOSABLE GROUNDING PAD |
| Generic Name | ELECTROSURGICAL RETURN ELECTRODE |
| Product Code | GXD |
| Date Received | 2020-03-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-17 |