FDA Adverse Event
Malfunction
Summary report: N
SUNBEAM
MDR report key: 1051330
·
Received May 23, 2008
Report
- Report Number
- 3004378258-2008-00021
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Report Date
- May 6, 2008
- Manufacturer
- JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS
- Product Code
- IRT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
BUNCHING IS ABUSE OF THE PRODUCT, AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. NO INJURIES WERE REPORTED WITH THIS INCIDENT. THIS INCIDENT IS DIRECT RESULT OF MISUSE/ABUSE OF THE PRODUCT. SEE SCANNED PAGES.
Description of Event or Problem · 1
HEATING PAD WAS RETURNED TO RETAILER AND THE ONLY INFORMATION PROVIDED WAS "BURN THROUGH MATERIAL". NO INJURY OR PROPERTY DAMAGES 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 | 832-515 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |