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

Model Number HP15AS

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 03/11/2014

Event Type  Injury  

Event Description

Consumer claims that the heating pad burned her shirt and skin.In following up with the consumer, she also claims that her couch was burned.

Manufacturer Narrative

Have not received unit from consumer.An investigation is currently being conducted for all hp15 (all models) heating pads.A supplementary report will be submitted upon completion of the investigation.

• 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: 3763321
• MDR Text Key: 4549088
• Report Number: 1222304-2014-00029
• 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: Other
• Type of Report: Initial
• Report Date: 03/11/2014

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: Other
• Device Model Number: HP15AS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 04/04/2014
• 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