MAUDE Adverse Event Report: CONAIR; HEATING PAD

Model Number HP01RB

Device Problems Device Remains Activated (1525); Failure to Shut Off (2939)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 03/09/2014

Event Type  Injury  

Event Description

Customer states that when she awoke from sleeping, she had 1st and 2nd degree burns on her left side.She claims the pad did not turn off.

Manufacturer Narrative

An investigation will be conducted upon receiving the product from the customer.Note, however, that the hp01 does not have an 'automatic off' function and it is stated on both the product and the instruction manual that the consumer should not fall asleep while using the product.

• Brand Name: CONAIR
• Type of Device: HEATING PAD
• Manufacturer Contact: one cummings point rd.; stamford, CT 06902
• MDR Report Key: 3763388
• MDR Text Key: 4466638
• Report Number: 1222304-2014-00032
• 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: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: HP01RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2014
• Was Device Evaluated by Manufacturer?: No
• Patient Sequence Number: 1