MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR HEATING MASSAGER

Model Number THP2

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 08/13/2015

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Consumer state she was dozing when she was using her massager.She claims she didn't feel the heat.She turned unit off, not unplugged and noticed it smelled.When she felt it , it was extremely hot.She takes pain medication.She received medical attention the day after the incident.The massager is a discontinued product.

Manufacturer Narrative

The unit was returned by the consumer and was tested and evaluated by engineering, who provided the following feedback: unit was received in good working condition.Massage switch was in the "off" position while the heat switch was in the "on"position when received.There are 2 switches located on the unit.The heat switch was still in the "on" position.The massage switch was shut off.Both switches work as designed.There was no device failure noticed.The instruction booklet was reviewed and in addition to other relevant warnings, the following specific warnings are included: always unplug this appliance from the electrical outlet immediately after using and before cleaning.Always check that massager is in off position, and speed slide is in l o w e s t/off setting before plugging into electrical outlet.

Event Description

Consumer state she was dozing when she was using her massager.She claims she didn't feel the heat.She turned unit off, not unplugged and noticed it smelled.When she felt it , it was extremely hot.She takes pain medication.She received medical attention the day after the incident.The massager is a discontinued product.

• Brand Name: CONAIR HEATING MASSAGER
• Type of Device: HEATING MASSAGER
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford CT 06902
• Manufacturer (Section G): CONAIR CORPORATION; 1 cummings point rd.; stamford CT 06902
• Manufacturer Contact: nina ruiz ; 1 cummings point rd; stamford, CT 06902 ; 2033519469
• MDR Report Key: 5070431
• MDR Text Key: 25550015
• Report Number: 1222304-2015-00017
• Device Sequence Number: 1
• Product Code: ISA
• 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
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: THP2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2007
• 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
• Patient Age: 7 MO