FDA Adverse Event
Injury
Summary report: N
NONIN WRISTOX2 PULSE OXIMETER
MDR report key: 9713232
·
Received February 14, 2020
Report
- Report Number
- 2183646-2020-00002
- Event Type
- Injury
- Date Received
- February 14, 2020
- Date of Event
- January 30, 2020
- Report Date
- February 14, 2020
- Manufacturer
- NONIN MEDICAL, INC.
- Product Code
- DQA
- PMA / PMN Number
- K102350
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REGARDING PATIENT INFORMATION, NOTHING FURTHER HAS BEEN DISCLOSED TO NONIN. PREEXISTING MEDICAL CONDITIONS COULD NOT BE DETERMINED. NONIN IS WAITING ON THE RETURN OF THE DEVICE, AND ONCE RECEIVED, WILL SUBJECT IT TO INVESTIGATION AND TESTING.
Description of Event or Problem · 1
THE PATIENT DESCRIBED GOING TO BED AROUND 10-11 PM, AND WAS AWAKEN BY A BURNING SENSATION AROUND 3-4 AM. HE THEN TOOK OFF THE DEVICE AND PLACED ICE CUBES ON THE BURN SITE, HIS RIGHT WRIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176917 | NONIN WRISTOX2 PULSE OXIMETER | WRIST-WORN PULSE OXIMETER | DQA | NONIN MEDICAL, INC. | 3150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |