FDA Adverse Event
Injury
Summary report: N
NEUROTHERM DISPOSABLE GROUNDING PAD
MDR report key: 4283286
·
Received November 21, 2014
Report
- Report Number
- 3002953813-2014-00012
- Event Type
- Injury
- Date Received
- November 21, 2014
- Date of Event
- October 20, 2014
- Report Date
- November 11, 2014
- Manufacturer
- NEUROTHERM, INC.
- Product Code
- GXD
- PMA / PMN Number
- K052878
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE GROUNDING PAD AND PACKAGING WAS DISCARDED BY THE FACILITY AND WAS NOT AVAILABLE FOR INVESTIGATION. LOT INFORMATION WAS NOT RECORDED PRIOR TO DISPOSAL. THE GENERATOR USED IN THE PROCEDURE WILL BE RETURNED AND EVALUATED. A FOLLOW UP WILL BE SENT ONCE THE INVESTIGATION IS COMPLETE, (B)(4).
Description of Event or Problem · 1
A PATIENT EXPERIENCED A BURN ON THE CALF WHERE THE GROUNDING PAD WAS PLACED. THREE BLISTERS 1 X 1.5CM) IN A TRIANGLE ABOUT 2 CM APART FORMED. PATIENT WAS NOT TREATED, ONLY MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 757934 | NEUROTHERM DISPOSABLE GROUNDING PAD | DISPOSABLE GROUNDING PAD | GXD | NEUROTHERM, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |