MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-07 for SUNBEAM 764 manufactured by Sunbeam Products, Inc..
[178214505]
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. Heating pad is bunched/crushed which shows abuse of the product and a violation of the instructions and warnings provided. This incident is the direct result of consumer misuse/abuse of the product.
Patient Sequence No: 1, Text Type: N, H10
[178214506]
An attorneys' office is filing a court summons notice under case reference number (b)(4) alleging that a heating pad was the cause of a burn to its client's body. There was not a report of property damages with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007790958-2020-00013 |
| MDR Report Key | 9683482 |
| Report Source | OTHER |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Device Manufacturer Date | 2016-06-22 |
| Date Added to Maude | 2020-02-07 |
| 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 64850 |
| Manufacturer Country | US |
| Manufacturer Postal | 64850 |
| Manufacturer Phone | 4174557441 |
| Manufacturer G1 | SKY EAGLE HOLDINGS CORP. |
| Manufacturer Street | NO. 128, CHUNG HWA RD., SEC. 2 |
| Manufacturer City | TAIPEI HSIEN, 236 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 236 |
| 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 | 2020-02-07 |
| Model Number | 764 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNBEAM PRODUCTS, INC. |
| Manufacturer Address | 2381 EXECUTIVE CENTER DR. BOCA RATON FL 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-07 |