MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number HP08FW

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

Patient Problems Unspecified Infection (1930); Superficial (First Degree) Burn (2685)

Event Date 12/13/2021

Event Type  Injury  

Manufacturer Narrative

01/06/2022 - we have requested the device be returned to the manufacturer for an investigation.To date we have not received the device.

Event Description

1/6/2022 - the consumer claims to have receive a burn on her left hip.The consumer stated the burn got infected and had to receive medical attention.

Manufacturer Narrative

01/06/2022 - we have requested the device be returned to the manufacturer for an investigation.To date we have not received the device.

Event Description

1/6/2022 - the consumer claims to have receive a burn on her left hip.The consumer stated the burn got infected and had to receive medical attention.

Event Description

(b)(6) 2022 - the consumer claims to have receive a burn on her left hip.The consumer stated the burn got infected and had to receive medical attention.

Manufacturer Narrative

(b)(6) 2022 - we have requested the device be returned to the manufacturer for an investigation.To date we have not received the device.(b)(6) 2022 - the consumer returned the device to the manufacturer for an investigation.Below is the manufacturers narrative: manufacturers narrative: sample was in a used condition and smelled like smoke.Unit showed no signs of overheating.Consumer claims the unit burned her left hip.Medical attention required.She states that she was "laying on top" of the heating pad - on her side.Unit was plugged into 120v outlet, wattage was 16w.Pad had 6 thermal couples taped to both sides.Highest temperature recorded was 59 c.This temperature complies with our internal specifications and complies with ul requirements.Testing showed unit performed as designed.Testing showed the unit's temperature was under allowable temperatures defined by ul.It also complied with our internal specifications.

• 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 06902
• MDR Report Key: 13177414
• MDR Text Key: 285922272
• Report Number: 1222304-2021-00041
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 74108448316
• UDI-Public: 74108448316
• 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: 12/27/2021

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: HP08FW
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other