FDA Adverse Event
Other
Summary report: N
NONIN
MDR report key: 1403306
·
Received June 8, 2009
Report
- Report Number
- 2183646-2009-00001
- Event Type
- Other
- Date Received
- June 8, 2009
- Date of Event
- May 12, 2009
- Report Date
- June 5, 2009
- Manufacturer
- NONIN MEDICAL, INC.
- Product Code
- DQA
- PMA / PMN Number
- K080255
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL MODEL# : 7500. INSTRUCTIONS FOR USE CAUTIONS OPERATOR TO INSPECT THE SENSOR APPLICATION SITE AT LEAST EVERY 6 TO 8 HOURS TO ENSURE CORRECT SENSOR ALIGNMENT AND SKIN INTEGRITY. PATIENT SENSITIVITY TO SENSORS MAY VARY DUE TO MEDICAL STATUS OR SKIN CONDITION. IT ALSO CAUTIONS OPERATOR NOT TO STRETCH THE ADHESIVE TAPE WHILE APPLYING THE SENSOR. THIS MAY CAUSE INACCURATE READINGS OR SKIN BLISTERS.
Description of Event or Problem · 1
IT WAS REPORTED THAT A (B)(6) BOY NAMED (B)(6) DEVELOPED A "BLISTER" ON HIS TOE FROM AN ALLEGED "BURN" FROM A 934 SENSOR USED WITH A MODEL 7500 PULSE OXIMETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONIN | FLEX SENSOR | DQA | NONIN MEDICAL, INC. | 934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Other |