FDA Adverse Event
Malfunction
Summary report: N
SUNBEAM
MDR report key: 2904753
·
Received December 4, 2012
Report
- Report Number
- 3007790958-2012-00032
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Report Date
- December 4, 2012
- Manufacturer
- JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS
- Product Code
- IRT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
BUNCHING/CRUSHING OF THE PAD IS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THIS INCIDENT IS DIRECT RESULT OF MISUSE/ABUSE OF THE PRODUCT.
Description of Event or Problem · 1
CONSUMER STATES THAT WHILE USING THE HEATING PAD ON HER STOMACH SHE NOTICED A BURNING SMELL AND DISCOVERED THE HEATING ELEMENTS HAD BURNED THROUGH THE COVER. NO INJURIES WERE REPORTED WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUNBEAM | HEATING PAD | IRT | JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS | 836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |