FDA Adverse Event
Injury
Summary report: N
KAZ INC
MDR report key: 96093
·
Received May 30, 1997
Report
- Report Number
- 1314800-1997-90006
- Event Type
- Injury
- Date Received
- May 30, 1997
- Date of Event
- March 20, 1997
- Report Date
- May 27, 1997
- Manufacturer
- KAZ, INC.
- Product Code
- KFZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
RECEIVED A LETTER FROM CONSUMER'S ATTORNEY ADVISING PT SUSTAINED SEVERE BURNS ARISING FROM THE USE OF A KAZ VAPORIZER. KAZ INSTRUCTIONS STATE 'KEEP VAPORIZER OUT OF THE REACH OF CHILDREN: STEAM CAN CAUSE BURNS." NO OTHER INSTRUCTIONS WAS GIVEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAZ INC | VAPORIZER | KFZ | KAZ, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 MO | Required Intervention |