FDA Adverse Event
Injury
Summary report: N
PRECISION MEDICAL INC.
MDR report key: 5091427
·
Received September 14, 2015
Report
- Report Number
- 2523148-2015-00002
- Event Type
- Injury
- Date Received
- September 14, 2015
- Date of Event
- August 4, 2014
- Report Date
- September 8, 2015
- Manufacturer
- PRECISION MEDICAL, INC.
- Product Code
- NFB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED ON (B)(6) 2014. PRECISION MEDICAL INC WAS NOTIFIED ON SEPTEMBER 2ND, 2015. THE PRODUCT INVOLVED WAS CONFISCATED BY THE FIRE MARSHALL AT THE TIME OF THE EVENT, AND HAS NOT BEEN EXAMINED BY PRECISION MEDICAL. THE EVENT OCCURRED IN THE PATIENT'S HOME. THE HUSBAND IS ON OXYGEN, USING THE PRECISION MEDICAL OXYGEN CONSERVER. AT THE TIME OF THE EVENT, THE HUSBAND WAS IN THE KITCHEN, AN EXPLOSION OCCURRED, INJURING BOTH THE HUSBAND AND WIFE.
Description of Event or Problem · 1
HUSBAND ON OXYGEN, THERE WAS AN EXPLOSION INJURING BOTH THE HUSBAND AND WIFE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607843 | PRECISION MEDICAL INC. | OXYGEN CONSERVER | NFB | PRECISION MEDICAL, INC. | 198705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |