FDA Adverse Event
Injury
Summary report: N
NONIN WRISTOX2 PULSE OXIMETER
MDR report key: 9696064
·
Received February 11, 2020
Report
- Report Number
- 2183646-2020-00001
- Event Type
- Injury
- Date Received
- February 11, 2020
- Date of Event
- January 17, 2020
- Report Date
- February 6, 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 HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
REGARDING PATIENT INFORMATION, NOTHING FURTHER HAS BEEN DISCLOSED TO NONIN. PREEXISTING MEDICAL CONDITIONS COULD NOT BE DETERMINED. ACTIONS TAKEN AFTER DEVICE WAS REMOVED FROM PATIENT COULD ALSO 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
PATIENT WOKE UP AROUND MIDNIGHT FEELING A BURNING SENSATION ON HER WRIST, WHERE THE NONIN WRISTOX2 DEVICE WAS PLACED. PATIENT THEN REMOVED THE DEVICE AND NOTICED THAT THE BATTERY DOOR HAD SLID DOWN 1/4 OF THE WAY. A BLISTER HAD BEEN FOUND LATER AT THE SAME LOCATION OF THE WRISTOX2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159509 | NONIN WRISTOX2 PULSE OXIMETER | WRIST-WORN PULSE OXIMETER | DQA | NONIN MEDICAL, INC. | 3150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |