FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 1141072
·
Received August 29, 2008
Report
- Report Number
- 1825511-2008-00012
- Event Type
- Injury
- Date Received
- August 29, 2008
- Date of Event
- July 28, 2008
- Report Date
- July 28, 2008
- Manufacturer
- PLAINFIELD-LOX-RX
- Product Code
- CAW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
COVIDIEN'S USER MANUALS, WARN, "DO NOT TOUCH LIQUID OXYGEN OR PARTS THAT HAVE BEEN IN CONTACT WITH LIQUID OXYGEN. LIQUID OXYGEN IS EXTREMELY COLD (-297 DEGREES FAHRENHEIT/-183 DEGREES CELSIUS). WHEN TOUCHED, LIQUID OXYGEN, OR PARTS OF THE EQUIPMENT THAT HAVE BEEN CARRYING LIQUID OXYGEN, CAN FREEZE SKIN AND BODY TISSUE."
Description of Event or Problem · 1
A PATIENT REPORTED THAT AFTER FILLING HIS DEVICE HIS HAND CAME INTO CONTACT WITH LIQUID OXYGEN AND WAS BURNED. THE PATIENT REQUESTED ADVICE ON HOW TO TREAT THE BURN. HE WAS ADVISED TO SEEK MEDICAL ATTENTION. THE PATIENT REFUSED TO PROVIDE HIS NAME OR CONTACT INFORMATION. THE MODEL AND SERIAL NUMBER OF THE DEVICE ARE NOT KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | UNK | CAW | PLAINFIELD-LOX-RX | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |