MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number HP15B

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Sparking (2595)

Patient Problem Insufficient Information (4580)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2020 the consumer has accepted the replacement product.Therefore, the consumer will not be sending the product to the manufacturer for an investigation.

Event Description

On (b)(6) 2020 the consumer claims the seam on the sparked and flames the wire.As a result the product burned.The consumer accepted a replacement product.

• Brand Name: CONAIR
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings poit rd.; stamford 06902
• Manufacturer Contact: 1 cummings point rd.,; stamford 06902
• MDR Report Key: 11027592
• MDR Text Key: 222676244
• Report Number: 1222304-2020-00033
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 74108104670
• UDI-Public: 74108104670
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HP15B
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR