MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number	HP15
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 02/26/2019 - since the consumer discontinued the complaint call and did not follow-up, it cannot be determined if the product will be returned to the manufacturer.Therefore, an investigation cannot be completed at this point in time.
Event or Problem Description
On 1/28/2019 - the consumer claims the product caught on fire.The consumer hung up on our call center prior giving a full description.

• Brand Name: CONAIR
• Common Device Name: HEATING PAD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• MDR Report Key: 8370046
• Report Number: 1222304-2019-00004
• Device Sequence Number: 11028432
• Product Code: IRT
• UDI-Device Identifier: 00074108355577
• UDI-Public: (01)00074108355577(10)1217DH(11)171201
• 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): 01/28/2019

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: HP15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2019
• 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