MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number	HP01XF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 06/04/2019 - the consumer agreed to received a new product and did not return the device for evaluation.Therefore, an inspection will not take place.
Event or Problem Description
On (b)(6) 2019 - the consumer claims that the product was smoking.The consumer agreed to receive a replacement.

• Brand Name: CONAIR
• Common Device Name: HEATING PAD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• MDR Report Key: 8666196
• Report Number: 1222304-2019-00014
• Device Sequence Number: 19397548
• Product Code: IRT
• UDI-Device Identifier: 00074108355560
• UDI-Public: (01)00074108355560(10)47818DH11)184701
• 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): 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Model Number: HP01XF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2019
• 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: 40 YR