MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-06-12 for SOFTHEAT HP950 NA manufactured by Kaz, Inc..
[3543076]
The consumer contacted kaz usa to inform us that she was burned by her heating pad. She stated the cover of the heating pad slipped off while she was sleeping and that is what caused a 3rd degree burn to her hand. The instructions for proper use state not to sleep with the heating pad.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2013-00023 |
| MDR Report Key | 3178034 |
| Report Source | 04 |
| Date Received | 2013-06-12 |
| Date of Report | 2013-06-03 |
| Date of Event | 2013-05-13 |
| Date Mfgr Received | 2013-05-13 |
| Date Added to Maude | 2013-06-19 |
| 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 | AMANDA CAREY |
| Manufacturer Street | 250 TURNPIKE ROAD |
| 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 | 2013-06-12 |
| Model Number | HP950 |
| Catalog Number | NA |
| Lot 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, INC. |
| Manufacturer Address | 250 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-12 |