MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number	HP15X
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	11/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018 the consumer discarded the product.Therefore, an investigation can not be complete.The consumer has also agreed to receive a replacement.
Event or Problem Description
On (b)(6) 2018 the consumer claims to have received a shock while in user of the product.The consumer states that the product is ripped a little because of the use.The consumer discarded the product and has 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: 8173552
• Report Number: 1222304-2018-00029
• Device Sequence Number: 1446727
• 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): 11/19/2018

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: HP15X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2018
• 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: 40 YR