FDA Adverse Event
Malfunction
Summary report: N
NEUROTHERM DISPOSABLE GROUNDING PAD
MDR report key: 3855738
·
Received April 21, 2014
Report
- Report Number
- 1226344-2014-00002
- Event Type
- Malfunction
- Date Received
- April 21, 2014
- Date of Event
- March 5, 2014
- Report Date
- March 31, 2014
- Manufacturer
- NEUROTHERM, INC.
- Product Code
- GXD
- PMA / PMN Number
- K052878
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, 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 MANUFACTURING RECORDS WERE REVIEWED WITH NO ABNORMALITIES FOUND. (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2014, A PATIENT RECEIVED A THIRD DEGREE BURN FROM A GROUNDING PAD DURING A SIMPLICITY PROCEDURE ON THE LEFT ABDOMEN. THE PATIENT WAS TREATED WITH SANTYL AND BIATAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241652 | NEUROTHERM DISPOSABLE GROUNDING PAD | DISPOSABLE GROUNDING PAD | GXD | NEUROTHERM, INC. | RF-DGP-S | 20131020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |