FDA Adverse Event
Malfunction
Summary report: N
NEUROTHERM DISPOSABLE GROUNDING PAD
MDR report key: 3980300
·
Received June 5, 2014
Report
- Report Number
- 3002953813-2014-00001
- Event Type
- Malfunction
- Date Received
- June 5, 2014
- Date of Event
- April 21, 2014
- Report Date
- May 8, 2014
- Manufacturer
- NEUROTHERM, INC.
- Product Code
- GXD
- PMA / PMN Number
- K052878
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE GROUNDING PAD WAS NOT RETURNED, THEREFORE VISUAL, PERFORMANCE, AND MECHANICAL/ PHYSICAL TESTING COULD NOT BE PERFORMED. THE MFG RECORDS WERE REVIEWED WITH NO ABNORMALITIES FOUND. (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2014, A PT HAD A NEUROTHERM SI JOINT SIMPLICITY RADIOFREQUENCY PROCEDURE. THE GROUNDING PAD WAS PLACED ON THE RIGHT CALF AND A FEW HOURS LATER POST PROCEDURE, THE PT CAME BACK TO CLINIC WITH TWO BURN BLISTERS ON TOP OF WHERE GROUNDING PAD WAS AND BELOW WHERE GROUNDING PAD WAS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330354 | NEUROTHERM DISPOSABLE GROUNDING PAD | DISPOSABLE GROUNDING PAD | GXD | NEUROTHERM, INC. | RF-DGP-S | 20130920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |