FDA Adverse Event
Injury
Summary report: N
KAZ INC
MDR report key: 138341
·
Received December 5, 1997
Report
- Report Number
- 1314800-1997-90011
- Event Type
- Injury
- Date Received
- December 5, 1997
- Date of Event
- December 1, 1997
- Report Date
- December 4, 1997
- Manufacturer
- KAZ INC.
- Product Code
- IRT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
CONSUMER FELL ASLEEP WITH PAD ON HER LEG, CONTRARY TO TO CO'S INSTRUCTION. WHEN SHE AWOKE, APPROX 1/2 HR LATER, SHE NOTICED A BURN ON HER LEG. PT WENT TO THE DR TO HAVE THE BLISTER DRAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KAZ INC | HEATING PAD | IRT | KAZ INC. | HP710 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |