MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-30 for SUNBEAM 764-689 manufactured by Sunbeam Products, Inc..
[176991754]
Consumer admits to laying on the heating pad which is abuse of the product and 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
[176991755]
Consumer alleges laying against her heating pad and received a burn on her right breast side. There was not a report of property damage with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007790958-2020-00010 |
| MDR Report Key | 9647695 |
| Report Source | CONSUMER |
| Date Received | 2020-01-30 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-09-17 |
| Date Added to Maude | 2020-01-30 |
| 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 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 | 2020-01-30 |
| Returned To Mfg | 2020-02-13 |
| Model Number | 764-689 |
| Device Availability | R |
| Device Age | DA |
| 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 FL 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-30 |