MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI SUNBEAM; VAPORIZER

Model Number 1361-705

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

There is an instruction that states, "never place a vaporizer where it is accessible to children" and consumer failed to perform that instruction.There is an instruction that states, "caution: to reduce the risk of burns, supervision is recommended when a vaporizer is used near children, invalids, or pets" and consumer failed to perform that instruction.There is an instruction that states, "position the unit so mist stream is aimed away from children, walls, and furniture" and the consumer failed to perform that instruction.

Event Description

Consumer alleges per (b)(6) post that her (b)(6) son was crawling and pulled himself upon the steam output of the product and received burns on both hands.There was not a report of property damage with this incident.

• Brand Name: SUNBEAM
• Type of Device: VAPORIZER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI; 2381 executive center dr.; boca raton FL 33431
• Manufacturer (Section G): CHUZHOU DONLIM ELECTRICAL APPLIANCES CO.,LTD.; no.1777 yangzi east road; chuzhou, anhui 23900 0; CH 239000
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 7219603
• MDR Text Key: 98246427
• Report Number: 3010341502-2018-00023
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1361-705
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: 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