MAUDE Adverse Event Report: CONAIR CORP. CONAIR HEATING PAD

Catalog Number HP01RB

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 04/16/2014

Event Type  Other  

Event Description

Consumer originally contacted us claiming that the heating pad blistered her neck due to becoming very hot quickly.She states that she laid on the pad for only a few minutes to treat her rheumatoid arthritis when she felt burning between her shoulder blades closer to her neck area.She claims to have blistered the size of a dollar and did not seek medical attention because she could not afford it.She claims to have received 2nd and 3rd degree burns and is treating herself with creams.She is currently taking a variety of medications, including prednisone, for preexisting conditions.

Manufacturer Narrative

Conair corporation has been communicating with the consumer who has asked to be compensated for medical bills that would be associated with wound care, since she feels that her current medical insurance will not cover the cost.We have asked the consumer to return the unit so that we can properly conduct a device failure evaluation, but consumer is currently discussing the situation with her attorney.Finally, consumer has admitted that there may not be anything wrong with her unit, but feels that we should not sell a heating pad that gets as hot as it does.Upon receipt of the product, a full device failure investigation will be conducted, and a supplemental report will be submitted to the fda, as applicable.

• Brand Name: CONAIR HEATING PAD
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR CORP.; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06904 ; 2033519000
• MDR Report Key: 3853735
• MDR Text Key: 4658887
• Report Number: 1222304-2014-00040
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: HP01RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other