FDA Adverse Event
Malfunction
Summary report: N
NEUROTHERM DISPOSABLE GROUNDING PAD
MDR report key: 4138247
·
Received September 29, 2014
Report
- Report Number
- 3002953813-2014-00010
- Event Type
- Malfunction
- Date Received
- September 29, 2014
- Date of Event
- August 29, 2014
- Report Date
- September 2, 2014
- Manufacturer
- NEUROTHERM, INC.
- Product Code
- GXD
- PMA / PMN Number
- K052878
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE GROUNDING PAD USED DURING THE PROCEDURE WAS NOT AVAILABLE FROM THE CUSTOMER FOR EVALUATION. HOWEVER, A PHOTO WAS PROVIDED AND SHOWED A GREAT AMOUNT OF HAIR ON THE PT AT THE SITE OF THE BURN.
Description of Event or Problem · 1
A PT RECEIVED A BURN FROM A GROUNDING PAD AFTER THE FIRST LESION OF AN RF PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 606475 | NEUROTHERM DISPOSABLE GROUNDING PAD | DISPOSABLE GROUNDING PAD | GXD | NEUROTHERM, INC. | RF-DGP-S | 20140321 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |