FDA Adverse Event
Malfunction
Summary report: N
NEUROTHERM DISPOSABLE GROUNDING PAD
MDR report key: 4059385
·
Received August 15, 2014
Report
- Report Number
- 3002953813-2014-00008
- Event Type
- Malfunction
- Date Received
- August 15, 2014
- Date of Event
- July 17, 2014
- Report Date
- July 18, 2014
- Manufacturer
- NEUROTHERM, INC.
- Product Code
- GXD
- PMA / PMN Number
- K052878
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE GROUNDING PAD UNDERWENT VISUAL AND PERFORMANCE TESTING UPON RETURN. THREE 1 MINUTE LESIONS AT 90 DEGREES CELSIUS WERE PERFORMED. EACH PROCEDURE HELD TEMPERATURE AND IMPEDANCE WITHIN SPECIFICATION. (B)(4).
Description of Event or Problem · 1
A PATIENT RECEIVED A BURN FROM A GROUNDING PAD ON THE MID SECTION OF THE BACK BETWEEN L1 AND L2. THE BURN WAS LOCATED ON TWO SIDES WHERE THE PAD CURVES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 491458 | NEUROTHERM DISPOSABLE GROUNDING PAD | GXD | NEUROTHERM, INC. | RF-DGP-S | 20140121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |