MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-04-19 for SOFTHEAT HP218 NA manufactured by Kaz, Inc..
[3277623]
The consumer reported receiving a second degree burn from the heating pad. The incident was reported to kaz by a third party. Burns of this nature can be caused by the consumer laying or leaning against the pad which is contrary to proper use instruction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2013-00018 |
| MDR Report Key | 3076576 |
| Report Source | 04 |
| Date Received | 2013-04-19 |
| Date of Report | 2013-04-16 |
| Date of Event | 2013-03-20 |
| Date Mfgr Received | 2013-03-20 |
| Date Added to Maude | 2013-04-26 |
| 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 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 | 2013-04-19 |
| Model Number | HP218 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAZ, INC. |
| Manufacturer Address | 250 TURNPIKE RD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-19 |