FDA Adverse Event
Injury
Summary report: N
NASAL ALAR SPO2 SENSOR
MDR report key: 8512559
·
Received April 14, 2019
Report
- Report Number
- 3010150334-2018-00001
- Event Type
- Injury
- Date Received
- April 14, 2019
- Date of Event
- February 1, 2018
- Report Date
- April 14, 2019
- Manufacturer
- XHALE ASSURANCE, INC
- Product Code
- DQA
- UDI-DI
- B213301112140
- PMA / PMN Number
- K171423
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
WOUND CARE COORDINATOR IDENTIFIED PRESSURE INJURIES ON BOTH ALA OF A PATIENT. THE LEFT SIDE WAS A STAGE 4 WITH OBSERVED PRESSURE INJURY INSIDE AND OUTSIDE THE NOSTRIL. THE RIGHT SIDE WAS A STAGE 3. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WILL BE UPDATED IF RELEVANT INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 305645 | NASAL ALAR SPO2 SENSOR | OXIMETER, PROBE | DQA | XHALE ASSURANCE, INC | 301-11214 | TR101733 | B213301112140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |