MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-06-27 for SOFTHEAT HP980 NA manufactured by Kaz Usa, Inc..
[21880069]
The consumer called to report that a heating pad that she owned was allegedly involved in a house fire. She stated that she had been lying against her heating pad, and then left the house with the heating pad still plugged in. There were no injuries or adverse events reported, but the house was a total loss as a result of this incident. Kaz is attempting to pick up the product for further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2014-00057 |
| MDR Report Key | 4001398 |
| Report Source | 04 |
| Date Received | 2014-06-27 |
| Date of Report | 2014-06-25 |
| Date of Event | 2014-05-09 |
| Date Mfgr Received | 2014-05-28 |
| Date Added to Maude | 2014-08-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SONJA WILKINSON |
| Manufacturer Street | 250 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5084907236 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFTHEAT |
| Generic Name | HEATING PAD |
| Product Code | IMA |
| Date Received | 2014-06-27 |
| Model Number | HP980 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAZ USA, INC. |
| Manufacturer Address | 250 TURNPIKE RD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-27 |