FDA Adverse Event
Malfunction
Summary report: N
THERMOPHORE AUTOMATIC MOIST HEAT PACK
MDR report key: 3172962
·
Received June 5, 2013
Report
- Report Number
- 1811605-2013-00083
- Event Type
- Malfunction
- Date Received
- June 5, 2013
- Date of Event
- May 11, 2013
- Report Date
- May 31, 2013
- Manufacturer
- BATTLE CREEK EQUIPMENT CO.
- Product Code
- IRT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OUR INSPECTION FOUND A SMALL CUT IN THE CORD NEAR THE SWITCH THAT COULD HAVE EXPOSED THE USER TO BARE WIRE. CORD BREAKAGE USUALLY OCCURS WHEN THE CORD IS REPEATEDLY OVER BENT NEAR THE SWITCH. WE HAVE INITIATED A CAPA PROJECT ((B)(4)) TO REDUCE THE OCCURRENCE OF THIS ISSUE.
Description of Event or Problem · 1
THE SELLER EMAILED TO US THAT THEIR CUSTOMER REPORTED THAT THE PAD SPARKED AND STOPPED WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249440 | THERMOPHORE AUTOMATIC MOIST HEAT PACK | ELECTRIC MOIST HEAT PACK | IRT | BATTLE CREEK EQUIPMENT CO. | 055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |