MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number HP01XF

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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/01/2021

Event Type  Injury  

Event Description

11/9/2021 - the consumer claims the product was stinging and burning on her stomach while in use.The consumer stated she was using a towel and cover with the product while in use.The consumer received medical attention.

Manufacturer Narrative

11/10/2021 - we have requested the device be returned to the manufacturer for an investigation.To date we have not received the device.

Manufacturer Narrative

11/10/2021 - we have requested the device be returned to the manufacturer for an investigation.To date we have not received the device.2/28/2022 - the consumer returned the device and an investigation was complete.Below is the manufacturers narrative: manufacturers narrative: customer claims they burned their stomach and sought medical attention.Pictures were provided.Unit was plugged into 120v.Wattage was 40w.Thermal couples were placed on the h eating pad in 6 positions.3 on each side mounted to the pvc under the cover.The unit was then covered with 2" ul recognized pad, to insulate it.Highest temperature recorded was 52 c after 1.5 hours or operating on high setting.This temperature complies with our internal specifications and those imposed by ul.This product is listed under standard ul130 and complies with rating and performance.No defect found no design problem found.Unit was tested and found to comply with ul130 and our internal requirements.

Event Description

(b)(6) 2021 - the consumer claims the product was stinging and burning on her stomach while in use.The consumer stated she was using a towel and cover with the product while in use.The consumer received medical attention.

• Brand Name: CONAIR
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT
• MDR Report Key: 12786033
• MDR Text Key: 282395827
• Report Number: 1222304-2021-00032
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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 Model Number: HP01XF
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other