MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number	HP01
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	12/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
04/9/2019 - we have requested the product be returned to the manufacturer.To date, we have not received the device.
Event or Problem Description
On (b)(6) 2019 - the consumer claims that she was sitting in the chair with the product on her back.The product got very hot and burned her back.The consumer's claim occur on (b)(6) 2016.The consumer was unsure who to call and waited until (b)(6) 2019 to report her claim.

• Brand Name: CONAIR
• Common Device Name: HEATING PAD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• MDR Report Key: 8495320
• Report Number: 1222304-2019-00006
• Device Sequence Number: 1704440
• Product Code: IRT
• UDI-Device Identifier: 00074108355560
• UDI-Public: 00074108355560
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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
• Operator of Device: No Information
• Device Model Number: HP01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR