MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number HP08F

Device Problem Device Emits Odor (1425)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

12/17/2020 - the consumer has accepted a replacement product.Therefore the manufacturer will not be received the product for an investigation.

Event Description

12/15/2020 - the consumer claims the product smelled like it was burning.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: 11027539
• MDR Text Key: 222697612
• Report Number: 1222304-2020-00031
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 74108359469
• UDI-Public: 74108359469
• 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

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HP08F
• 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 Outcome(s): Other
• Patient Age: 50 YR