FDA Adverse Event
Malfunction
Summary report: N
NEUROTHERM DISPOSABLE RADIOFREQUENCY CANNULA
MDR report key: 4071473
·
Received August 13, 2014
Report
- Report Number
- 3002953813-2014-00007
- Event Type
- Malfunction
- Date Received
- August 13, 2014
- Date of Event
- July 7, 2014
- Report Date
- July 15, 2014
- Manufacturer
- NEUROTHERM, INC.
- Product Code
- GXI
- PMA / PMN Number
- K000073
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CANNULA USED IN THE PROCEDURE WAS NOT RETAINED BY THE FACILITY FOR INVESTIGATION. THE LOT NUMBER WAS NOT RECORDED AND THE PACKAGING WAS DISCARDED. 2013 AND 2014 COMPLAINT LOTS WERE REVIEWED FOR LOTS PURCHASED BY THE FACILITY. NO OTHER COMPLAINTS WERE RECORDED. TO DATE FACILITY HAS NOT PROVIDED ANY ADDITIONAL INFO REGARDING BURN SEVERITY OR PRODUCT INFO TO SUPPLEMENT INVESTIGATION. (B)(4).
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 |
|---|---|---|---|---|---|---|---|
| 483362 | NEUROTHERM DISPOSABLE RADIOFREQUENCY CANNULA | GXI | NEUROTHERM, INC. | SL-C505-22 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |