MAUDE Adverse Event Report: CONAIR CORP. CONAIR; HEATING PAD

Model Number HP15RB

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem Burn, Thermal (2530)

Event Date 03/01/2014

Event Type  Injury  

Event Description

Consumer was using her heating pad and claims that the pad slipped out of the cover and burned her lower right hip twice (the slip should be snapped).She also claims that the auto shut off feature on the device does not work and that one snap unsnapped causing the plastic pad to come out of the cover.

Manufacturer Narrative

The product is currently being evaluated.A supplemental report will be submitted upon investigation completion.

• Brand Name: CONAIR
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR CORP.; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 3763299
• MDR Text Key: 18920700
• Report Number: 1222304-2014-00027
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/07/2014

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: HP15RB
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/19/2014
• Date Manufacturer Received: 03/07/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other