MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI SUNBEAM; HOT/COLD WATER BOTTLE

Model Number 1773-500

Device Problem Material Rupture (1546)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: SUNBEAM
• Type of Device: HOT/COLD WATER BOTTLE
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI; 2381 executive center dr.; boca raton FL 33431
• Manufacturer (Section G): WUXI TOPTEAM CO., LTD; no. 58 guangliang north road; wuxing village; yangzhou, jiangsu ; CH
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 6284819
• MDR Text Key: 66005741
• Report Number: 3004668337-2017-00021
• 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: Other
• Type of Report: Initial
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1773-500
• Was Device Available for Evaluation?: 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