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 HP980 NA manufactured by Kaz, Inc..
[18280564]
The consumer reported receiving third degree burns to her arm from use of the heating pad. She stated she uses the heating pad for half the day with her arm resting on the pad and then when she goes to bed. The instructions for proper use state not to lean or lay against the heating pad or to use while sleeping.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2013-00019 |
| MDR Report Key | 3076562 |
| Report Source | 04 |
| Date Received | 2013-04-19 |
| Date of Report | 2013-04-16 |
| Date of Event | 2013-03-26 |
| Date Mfgr Received | 2013-03-26 |
| 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 | HP980 |
| 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 |