MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number HP01RB

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 12/26/2017

Event Type  Injury  

Manufacturer Narrative

On 2/22/2018 - we have requested the device be returned to the manufacturer.To date we have not received the device.

Event Description

On 2/16/2018 - the consumer claims to have received a burn under her left breast and sustained a burn.Medical attention was received.

• Brand Name: CONAIR
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd; stamford 06902
• Manufacturer Contact: 1 cummings point rd; stamford,
• MDR Report Key: 7289604
• MDR Text Key: 100705441
• Report Number: 1222304-2018-00003
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 74108104670
• UDI-Public: 74108104670
• Combination Product (y/n): N
• 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: 02/13/2018

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
• Device Operator: No Information
• Device Model Number: HP01RB
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR