MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number HP08F

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

Patient Problem Burn, Thermal (2530)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Our legal team has been in contact with the consumers attorney.We have requested the device be returned to the manufacturer for an investigation.To date, we have not received the device.

Event Description

Per the consumers attorney, the consumer expierienced a serious burn while in use of the product.The consumer received medical attention and is looking for compensation.Our legal dept.Has requested the product be returned so an investigation can be performed.We recieved this claim on 1/18/2021.

• Brand Name: CONAIR
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford 06902
• MDR Report Key: 11228566
• MDR Text Key: 228610633
• Report Number: 1222304-2021-00003
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2021

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 Operator: No Information
• Device Model Number: HP08F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: 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