FDA Adverse Event
Malfunction
Summary report: N
THERMOPHORE AUTOMATIC MOIST HEAT PACK
MDR report key: 3170616
·
Received April 18, 2013
Report
- Report Number
- 1811605-2013-00047
- Event Type
- Malfunction
- Date Received
- April 18, 2013
- Date of Event
- March 15, 2013
- Report Date
- March 25, 2013
- Manufacturer
- BATTLE CREEK EQUIPMENT COMPANY
- Product Code
- IRT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE USER REPORTED THAT PAD SPARKED. UPON FURTHER INVESTIGATION, WE FOUND THAT THE CORD HAD BEEN SEVERED BY AN EXTERNAL SOURCE. OUR INVESTIGATION SHOWS THE SPARKING OCCURRED AS THE CORD WAS SEVERED. BASED ON THE OVERALL CONDITION OF THE PAD, WE CONCLUDED THAT THE HEATING PAD WAS NOT USED IN ACCORDANCE WITH OUR INSTRUCTIONS.
Description of Event or Problem · 1
THE USER REPORTED THAT SHE WAS SHOCKED. UPON FURTHER INVESTIGATION, WE FOUND THAT THE CORD HAD BEEN SEVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 168577 | THERMOPHORE AUTOMATIC MOIST HEAT PACK | ELECTRIC MOIST HEAT PACK | IRT | BATTLE CREEK EQUIPMENT COMPANY | 055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |