FDA Adverse Event
Malfunction
Summary report: N
THERMOPHORE ARTHRITIS PAD
MDR report key: 1812734
·
Received August 16, 2010
Report
- Report Number
- 1811605-2010-00289
- Event Type
- Malfunction
- Date Received
- August 16, 2010
- Date of Event
- April 1, 2010
- Report Date
- August 9, 2010
- Manufacturer
- BATTLE CREEK EQUIPMENT CO.
- Product Code
- IRT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT THE UNIT REMAINED ON. OUR TESTING REVEALED THAT THE SWITCH BUTTON IS STUCK.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIT REMAINED "ON" WHEN THE DEAD-MAN SWITCH WAS NOT BEING HELD DOWN TO ACTIVATE THE HEAT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERMOPHORE ARTHRITIS PAD | ELECTRIC MOIST HEAT PACK | IRT | BATTLE CREEK EQUIPMENT CO. | 055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |