MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATED MITTS

Model Number JBHM1NC

Device Problems Fire (1245); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Other  

Event Description

The distributor has claimed that his customers are providing feedback that the product gets too hot even on low setting.One of their customer indicated that the unit caught on fire.The unit that has been claimed to have caught on fire did not produce any injury.

Manufacturer Narrative

The distributor indicated that he is receiving feedback from his customers regarding the units getting "too hot." one unit is claimed to have caught on fire.The units are used at salons and professional beauty care establishments.An investigation is being conducted to determine if the product is functioning in accordance to its specification, and to determine the root cause of the problem.The unit that was caught on fire was not returned by the consumer.The engineering team could not recreate the event with a new unit from stock.It was determined, however, that the unit is working in accordance to its specifications.In addition, six cases were removed from stock and are currently being investigated.Upon completion of the investigation, a supplemental report, in additional to an investigation report will be submitted.

• Brand Name: CONAIR
• Type of Device: HEATED MITTS
• Manufacturer (Section D): CONAIR CORPORATION; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902 ; 2033519000
• MDR Report Key: 3763492
• MDR Text Key: 4418470
• Report Number: 1222304-2014-00033
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: JBHM1NC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other