MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-14 for NONIN WRISTOX2 PULSE OXIMETER 3150 110204-001 manufactured by Nonin Medical, Inc..
[180340811]
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.
Patient Sequence No: 1, Text Type: N, H10
[180340812]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183646-2020-00002 |
| MDR Report Key | 9713232 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRENT GEIGER |
| Manufacturer Street | 13700 1ST AVE. N |
| Manufacturer City | PLYMOUTH, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 5772670 |
| Manufacturer G1 | NONIN MEDICAL, INC. |
| Manufacturer Street | 13700 1ST AVE. N |
| Manufacturer City | PLYMOUTH, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NONIN WRISTOX2 PULSE OXIMETER |
| Generic Name | WRIST-WORN PULSE OXIMETER |
| Product Code | DQA |
| Date Received | 2020-02-14 |
| Model Number | 3150 |
| Catalog Number | 110204-001 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NONIN MEDICAL, INC. |
| Manufacturer Address | 13700 1ST AVE. N PLYMOUTH, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-14 |