FDA Adverse Event
Malfunction
Summary report: N
NEUROTHERAM DISPOSABLE GROUNDING PAD
MDR report key: 3915771
·
Received June 12, 2014
Report
- Report Number
- 3002953813-2014-00005
- Event Type
- Malfunction
- Date Received
- June 12, 2014
- Date of Event
- May 13, 2014
- Report Date
- May 14, 2014
- Manufacturer
- NEUROTHERM, INC.
- Product Code
- GXD
- PMA / PMN Number
- K052878
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE GROUNDING PAD HAS NOT YET BEEN RETURNED, THEREFORE, IT HAS NOT UNDERGONE VISUAL, PERFORMANCE AND MECHANICAL/PHYSICAL TESTING. DETAILS OF THE PROCEDURE, BURN AND THE LOT NUMBER OF THE GROUNDING PAD ARE UNCLEAR. A F/U REPORT WILL BE INITIATED WHEN RESPONSE IS OBTAINED FROM REQUESTS FOR INFO AND AFTER EVAL IS COMPLETE; (B)(4) 2014.
Description of Event or Problem · 1
A PT WAS BURNED BY A GROUNDING PAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346558 | NEUROTHERAM DISPOSABLE GROUNDING PAD | DISPOSABLE GROUNDING PAD | GXD | NEUROTHERM, INC. | RF-DGP-L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |