MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-27 for SUNBEAM 1773-500 manufactured by Sunbeam Products, Inc., Dba Jarden Consumer Soluti.
[66005741]
There is an instruction that states, "do not fold, sit on, or lie on water bottle during use". There is an instruction that states, "never use boiling water in water bottle, even very hot tap water can cause burns". Consumer has not returned the product.
Patient Sequence No: 1, Text Type: N, H10
[66005742]
Consumer alleges his father leaned against the hot/cold water bottle on his back and it ruptured causing burns to his left leg and gential area. There was not a report of property damage with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004668337-2017-00021 |
| MDR Report Key | 6284819 |
| Date Received | 2017-01-27 |
| Date of Report | 2017-01-27 |
| Date Added to Maude | 2017-01-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 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 | WUXI TOPTEAM CO., LTD |
| Manufacturer Street | NO. 58 GUANGLIANG NORTH ROAD WUXING VILLAGE |
| Manufacturer City | YANGZHOU, JIANGSU |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUNBEAM |
| Generic Name | HOT/COLD WATER BOTTLE |
| Product Code | FPF |
| Date Received | 2017-01-27 |
| Model Number | 1773-500 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI |
| Manufacturer Address | 2381 EXECUTIVE CENTER DR. BOCA RATON FL 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-27 |