MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC. DKA JARDEN CONSUMER SOLUTIONS, 2381 SUNBEAM; HOT OR COLD WATER BOTTLE

Model Number 1773-500

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: SUNBEAM
• Type of Device: HOT OR COLD WATER BOTTLE
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC. DKA JARDEN CONSUMER SOLUTIONS, 2381 ; executive center dr.; boca raton FL
• Manufacturer (Section G): WUXI TOPTEAM CO.LTD; room 2104, mingzhu mansion 88-2 ; zhongshan rd; wuxi, jiangsu 21400 1; CH 214001
• Manufacturer Contact: tracie jones ; po box 2391; wichita, KS 67201-0000 ; 3162197325
• MDR Report Key: 5130857
• MDR Text Key: 27691002
• Report Number: 3005327017-2015-00132
• Device Sequence Number: 1
• Product Code: FPF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Not Applicable
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1773-500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other