MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number	HP01X
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 4/10/2018 - we have requested be returned to the manufacturer for an investigation.To date we have not received the device.
Event or Problem Description
On 04/10/2018 - per the consumers attorney, the consumer was injured while in use of this product.We are currently waiting for the attorney to provide additional details that caused the injury.

• Brand Name: CONAIR
• Common Device Name: HEATING PAD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• MDR Report Key: 7412208
• Report Number: 1222304-2018-00005
• Device Sequence Number: 1372785
• 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): 03/13/2018

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: HP01X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2018
• 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