FDA Adverse Event
Injury
Summary report: N
DRIVE DEVILBISS HEALTHCARE
MDR report key: 19818545
·
Received July 24, 2024
Report
- Report Number
- 2438477-2024-00040
- Event Type
- Injury
- Date Received
- July 24, 2024
- Date of Event
- October 10, 2021
- Report Date
- July 24, 2024
- Manufacturer
- DANYANG AIRTECH CO., LTD
- Product Code
- CAN
- UDI-DI
- 00822383283210
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A REGULATOR BY A LETTER FROM AN ATTORNEY, WHICH STATES THE END USER WAS REFILLING AN OXYGEN TANK ON WHICH THE REGULATOR WAS PLACED, WHEN LEAKING OXYGEN CAUSED A FIRE TO TEMPORARILY IGNITE AND THE END USER TO SUSTAIN 3RD DEGREE BURNS TO HER LEFT HAND. DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT THROUGH PARTICIPATION IN A LAWSUIT. NO SPECIFIC DEFECT IN THE REGULATOR HAS BEEN IDENTIFIED. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2371686 | DRIVE DEVILBISS HEALTHCARE | REGULATOR, PRESSURE, GAS CYLINDER | CAN | DANYANG AIRTECH CO., LTD | 18302GMN | 00822383283210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |