MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-09-22 for SUNBEAM 1773-500 manufactured by Sunbeam Products, Inc. Dka Jarden Consumer Solutions, 2381.
[27691002]
Consumer did not follow the warnings and instructions which state: "never use boiling water in water bottle, even very hot tap water can cause burns" and "to test for leakage, turn bottle upside down and press on it firmly. " this incident is the direct result of consumer not heeding the warnings and instructions provided.
Patient Sequence No: 1, Text Type: N, H10
[27691003]
Consumer is claiming that he was using the hot water bottle for low back pain when the seal allegedly leaked and caused burns to his back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005327017-2015-00132 |
| MDR Report Key | 5130857 |
| Report Source | CONSUMER |
| Date Received | 2015-09-22 |
| Date of Report | 2015-09-22 |
| Date Added to Maude | 2015-10-06 |
| 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 | TRACIE JONES |
| Manufacturer Street | PO BOX 2391 |
| Manufacturer City | WICHITA KS 672010000 |
| Manufacturer Country | US |
| Manufacturer Postal | 672010000 |
| Manufacturer Phone | 3162197325 |
| Manufacturer G1 | WUXI TOPTEAM CO.LTD |
| Manufacturer Street | ROOM 2104, MINGZHU MANSION 88-2 ZHONGSHAN RD |
| Manufacturer City | WUXI, JIANGSU 214001 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 214001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUNBEAM |
| Generic Name | HOT OR COLD WATER BOTTLE |
| Product Code | FPF |
| Date Received | 2015-09-22 |
| Model Number | 1773-500 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNBEAM PRODUCTS, INC. DKA JARDEN CONSUMER SOLUTIONS, 2381 |
| Manufacturer Address | EXECUTIVE CENTER DR. BOCA RATON FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-22 |