MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-07-28 for SOFTHEAT HP980 NA manufactured by Kaz Usa, Inc..
[4773867]
A consumer reported that she was allegedly burned while using a heating pad. She stated that she received a third or fourth degree burn under her right breast from this incident. She also stated that she is currently under a doctor's care, and may require surgery if the burn does not heal properly. Burns of this nature are most likely caused by the consumer laying or leaning against the pad which is contrary to proper use instructions. The product has a clear warning that states the product is intended for use on top of the body, and consumers should not sit against or lay on top of the heating pad. The instructions for use also have a warning to never place the pad between yourself and a chair, sofa, bed, or pillow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2014-00063 |
| MDR Report Key | 4003462 |
| Report Source | 04 |
| Date Received | 2014-07-28 |
| Date of Report | 2014-07-25 |
| Date of Event | 2014-06-22 |
| Date Mfgr Received | 2014-07-11 |
| Date Added to Maude | 2014-08-12 |
| 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 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 | 2014-07-28 |
| Model Number | HP980 |
| 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 USA, INC. |
| Manufacturer Address | 250 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-28 |