MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-27 for SOFTHEAT HP750 manufactured by Kaz Usa, Inc., A Helen Of Troy Company.
[185292702]
A consumer stated that she had allegedly received burns on her buttocks while using a heating pad approximately 3 months ago, and medical attention was sought about a month after the incident occurred. She stated that she received a third degree burn, and that follow-up care will be needed. The consumer stated that she was laying on top of the heating pad at the time that the injury occurred. The instructions for proper use clearly state "danger: if used improperly, this product can cause severe burns to skin, and damage to property. ", "do not use while sleeping. ", and "this heating pad is intended for use on top of your body. Do not sit or lie on top of the heating pad. Never place pad between yourself and chair, sofa, bed or pillow. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314800-2020-00016 |
| MDR Report Key | 9890297 |
| Report Source | CONSUMER |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2014-03-10 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SONJA WILKINSON |
| Manufacturer Street | 400 DONALD LYNCH BOULEVARD SUITE 300 |
| Manufacturer City | MARLBOROUGH, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 4907236 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFTHEAT |
| Generic Name | ELECTRIC HEATING PAD |
| Product Code | IRT |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-23 |
| Model Number | HP750 |
| Lot Number | 06914SMT |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAZ USA, INC., A HELEN OF TROY COMPANY |
| Manufacturer Address | MARLBOROUGH, MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-27 |