MAUDE Adverse Event Report: CONAIR CORP. CONAIR; HEATED MITTS

Model Number JBHM1NC

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2013

Event Type  No Answer Provided  

Event Description

Consumer's client had her hands in the mitts when they burned.The client did not get burned.

Manufacturer Narrative

The device was evaluated by the engineering department.The burn occurred in a area where there is no heater or electrical devices.The rope heater that surrounds the burn mark is also not overheated.The actual cause of the burn cannot be determined.New mitts are being tested to determine overheating, and a supplementary report will be submitted.

• Brand Name: CONAIR
• Type of Device: HEATED MITTS
• Manufacturer (Section D): CONAIR CORP.; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 3763453
• MDR Text Key: 4488063
• Report Number: 1222304-2014-00031
• Device Sequence Number: 1
• Product Code: IRT
• 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: 10/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: JBHM1NC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other