MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-13 for SUNBEAM 756-500 manufactured by Sunbeam Products, Inc..
[189037487]
Consumer admits to sleeping while using the heating pad which is a violation of the instructions and warnings provided. There is an instruction that states, "do not sit on, against, or crush pad-avoid sharp folds. Place pad on top of and not under the part of body needing heat" and consumer failed to perform that instruction. There is an instruction that states, "burns can occur regardless of control setting, check skin under pad frequently" and consumer failed to perform that instruction.
Patient Sequence No: 1, Text Type: N, H10
[189037488]
An attorneys' office is filing a letter notice under case reference number (b)(4) alleging that a heating pad was the cause of a burn to its client's body while sleeping against it during use. There was not a report of property damage with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010805625-2020-00014 |
| MDR Report Key | 9706354 |
| Report Source | OTHER |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date Added to Maude | 2020-02-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL MILES |
| Manufacturer Street | 303 NELSON AVE. |
| Manufacturer City | NEOSHO, MO |
| Manufacturer Country | US |
| Manufacturer Phone | 4557441 |
| Manufacturer G1 | ZHEIJANG LUMENG HEALTH & TECHNOLOGY CO., LTD |
| Manufacturer Street | NORTHWEST OF QUNXIAN ROAD AND CENTER AVENUE |
| Manufacturer City | PAOJIANG, 31200 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 31200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNBEAM |
| Generic Name | HEATING PAD |
| Product Code | IRT |
| Date Received | 2020-02-13 |
| Model Number | 756-500 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNBEAM PRODUCTS, INC. |
| Manufacturer Address | 2381 EXECUTIVE CENTER DR. BOCA RATON, FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-13 |