FDA Adverse Event
Malfunction
Summary report: N
NEUROTHERM DISPOSABLE RADIOFREQUENCY CANNULA
MDR report key: 4021337
·
Received July 8, 2014
Report
- Report Number
- 3002953813-2014-00006
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- June 12, 2014
- Report Date
- June 12, 2014
- Manufacturer
- NEUROTHERM, INC.
- Product Code
- GXI
- PMA / PMN Number
- K000073
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CANNULA UNDERWENT VISUAL, MECHANICAL, AND PHYSICAL TESTING. NO ABNORMALITIES WERE FOUND. THE NEEDLE INSULATION WAS TESTED AND WAS FOUND TO BE WITHIN SPECIFICATION. PHOTOGRAPHS OF THE BURN SUGGESTED THE CANNULA WAS INSERTED FAR ENOUGH INTO THE PATIENT TO WHERE THE HUB TOUCHED THE SKIN. SIMULATED USE TESTED WAS PERFORMED USING CHICKEN BREAST. THE BURNS WERE REPLICATED WHEN THE CANNULA WAS INSERTED FAR ENOUGH FOR THE HUB TO BE TOUCHING THE MEAT.
Description of Event or Problem · 1
A PATIENT RECEIVED A BURN FROM A CANNULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398263 | NEUROTHERM DISPOSABLE RADIOFREQUENCY CANNULA | DISPOSABLE RADIOFREQUENCY CANNULA | GXI | NEUROTHERM, INC. | S-1510-B-18 | 140531-1A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |