MAUDE Adverse Event Report: CONAIR LLC. CONAIR; HEATING PAD

Model Number HP01

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

Patient Problem Burn(s) (1757)

Event Date 03/21/2022

Event Type  Injury  

Manufacturer Narrative

05/04/2022 - the device was returned to the manufacturer and is currently under investigation.

Event Description

(b)(6) 2022 - the consumer claims to have received a burn on her leg while in use of the product.The product was returned on 5/6/2022 and is currently being investigated.

Manufacturer Narrative

05/04/2022 - the device was returned to the manufacturer and is currently under investigation.6/2/2022 - the device was evaluated by the manufacturer.Below is the manufacturers narrative: manufacturers narrative: product was returned in good working condition.4/06/2022.Unit was run per ul130 temp set up.Temperature never exceeded 55c ( 131 f).Ul's limit is 70 c and conairs limit is 60c.We are under both the safety lab's and conairs temperature limits.Unit is not longer manufactured at this vendor.New construction was implemented in 2018.This construction is no longer manufactured.

Event Description

03/22/2022 - the consumer claims to have received a burn on her leg while in use of the product.The product was returned on 5/6/2022 and is currently being investigated.

Event Description

03/22/2022 - the consumer claims to have received a burn on her leg while in use of the product.The product was returned on 5/6/2022 and is currently being investigated.

Manufacturer Narrative

05/04/2022 - the device was returned to the manufacturer and is currently under investigation.6/2/2022 - the device was evaluated by the manufacturer.Below is the manufacturers narrative: 07/06/2022 - the was confusion between different complaints.Therefore the original manufacturer's narrative date 6/2/2022 was incorrect.Below is the corrected manufacturers narrative manufacturers narrative: unit was run per ul130 temp set up.Temperature never exceeded 55c ( 131 f).Ul's limit is 70 c and conairs limit is 60c.We are under both the safety lab's and conairs temperature limits.Unit performed as expected.Temperatures were lowered from competitive and safety labs limits to reduce burns.Consumer needs to be more diligent is checking skin prior to burns.

• 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: 14285877
• MDR Text Key: 290771609
• Report Number: 1222304-2022-00010
• Device Sequence Number: 1
• Product Code: IRT
• 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,Followup
• Report Date: 03/22/2022

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: HP01
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 04/06/2022; 04/06/2022
• Supplement Dates FDA Received: 06/02/2022; 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other