FDA Adverse Event
Malfunction
Summary report: N
HEAT THERAPY PUMP
MDR report key: 2031658
·
Received February 24, 2011
Report
- Report Number
- 1313850-2011-00018
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- January 26, 2011
- Report Date
- January 26, 2011
- Manufacturer
- GAYMAR INDUSTRIES, INC.
- Product Code
- ILO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A TP500C IS OVERHEATING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEAT THERAPY PUMP | HEAT PUMP | ILO | GAYMAR INDUSTRIES, INC. | TP500C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |