MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-09 for SUNBEAM 720-905 manufactured by Sunbeam Products, Inc..
[174785941]
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, "do not place anything over the heating pad while in use or plugged in, such as a towel, blanket, clothing, or any other insulating material, and never allow heating pad to wrap around itself" 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
[174785942]
Consumer's daughter alleges her mother had leaned against the heating pad while in her recliner watching television and received a burn on her right hip near her buttock. There was not a report of property damage with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010805625-2020-00001 |
| MDR Report Key | 9569295 |
| Report Source | OTHER |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-12-14 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2016-06-29 |
| Date Added to Maude | 2020-01-09 |
| 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 | 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 | 2020-01-09 |
| Returned To Mfg | 2020-01-10 |
| Model Number | 720-905 |
| 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 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-09 |