MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number HPO01XF

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

Patient Problem Burn, Thermal (2530)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2020 - we have requested the device to returned to the manufacturer for evaluation.To date, we have not received the device.

Event Description

(b)(6) 2020 - the incident occurred on (b)(6) 2020 but the consumer did not report this claim until (b)(6) 2020.The consumer claims she received a burn while in use of the product.Medical attention was not received.

Manufacturer Narrative

(b)(6) 2020: we have requested the device to be returned to the manufacturer for evaluation.To date, we have not received the device.(b)(6) 2020: the device was returned on (b)(6) 2021 and the evaluation was complete.Below is the manufacturer narrative: heating pad was energized with 120v and was temperature tested over 1 hour.Unit complied with conair specifications and ul temperature limits.Instructions limit use to 30 min and requires consumer to "check frequently" if sensitive skin.The heating pad was in good working condition when received.As skin sensitivity varies from person to person, we develop heating pads to comply with ul temperature limits.Most all heating pads sold in america must comply with the same limits.Testing confirmed there was no malfunction and the heating pad complied with all temperature limits.I have attached an ib that explains the potential or burns and to look frequently at the area to be treated.

Event Description

(b)(6) 2020: the incident occured on (b)(6) 2020 but the consumer did not report the claim until (b)(6) 2020.The consumer claims she received a burn while in use of the product.Medical attention was not received.

Manufacturer Narrative

12/1/2020 - we have requested the device be returned to the manufacturer for evaluation.To date, we have not received the device.2/4/2020 - the device was returned on 1/6/2021 and the evaluation was complete.Below is the manufacturers narrative; manufacturer narrative: 2/4/2020 - the device was returned on 1/6/2021 and the evaluation was complete.Below is the manufacturer narrative: heating pad was energized with 120v and was temperature tested over 1 hour.Unit complied with conair specifications and ul temperature limits.Instructions limit use to 30 min and requires consumer to "check frequently" if sensitive skin.The heating pad was in good working condition when received.As skin sensitivity varies from person to person, we develop heating pads to comply with ul temperature limits.Most all heating pads sold in america must comply with the same limits.Testing confirmed there was no malfunction and the heating pad complied with all temperature limits.I have attached an ib that explains the potential or burns and to look frequently at the area to be treated.4/27/2021 - per the fda's request, submitted a supplemental mdr that does not include the age and dob.

Event Description

12/1/2020 - the incident occured on (b)(6) 2020 but the consumer did not report the claim until 11/4/2020.The consumer claims she received a burn while in use of the product.Medical attention was not received.4/27/2021 - per the fda's request, submitted a supplemental mdr that does not include the age and dob.

• Brand Name: CONAIR
• Type of Device: HEATING PAD
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford CT 06902
• MDR Report Key: 10929419
• MDR Text Key: 219102142
• Report Number: 1222304-2020-00025
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 74108355560
• UDI-Public: 74108355560
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2021

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: HPO01XF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/04/2021; 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR