FDA Adverse Event
Injury
Summary report: N
NEWLIFE INTENSITY
MDR report key: 3022797
·
Received March 22, 2013
Report
- Report Number
- 1319044-2013-00004
- Event Type
- Injury
- Date Received
- March 22, 2013
- Date of Event
- February 21, 2013
- Report Date
- March 22, 2013
- Manufacturer
- AIRSEP CORP.
- Product Code
- CAW
- PMA / PMN Number
- K960309
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRESENTLY WAIT FOR THE DEVICE TO RETURN FROM HOMECARE PROVIDER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE DEVICE IS EVALUATED.
Description of Event or Problem · 1
PATIENT IGNITED HIMSELF AND THE OXYGEN CONCENTRATOR. THE PATIENT WAS SMOKING MARIJUANA AT THE TIME OF THE INCIDENT AND SUFFERED BURNS TO HIS FOOT, HAND, AND TO FACE, NOSTRIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119939 | NEWLIFE INTENSITY | OXYGEN CONCENTRATOR | CAW | AIRSEP CORP. | AS094-100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization |