MAUDE Adverse Event Report: CONAIR LLC CONAIR; HEATING PAD

Model Number HP01XF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 01/11/2019

Event Type  Injury  

Event Description

On 3/9/2022 - the date of incident did not occur until (b)(6) 2019 and we have just received notification from the consumers attorney.The consumer claims to have received a 3rd degree burn while in use of the product.

Manufacturer Narrative

On 04/04/2022 - to date, the incident is part of a litigation.We will not be receiving the device for an inspection until the discovery process is complete.

• Brand Name: CONAIR
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR LLC; 1 cummings point rd.; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 13994043
• MDR Text Key: 288474501
• Report Number: 1222304-2022-00007
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 74108355560
• UDI-Public: 74108355560
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2022

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
• Device Model Number: HP01XF
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other