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

Model Number HP15

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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 05/01/2022

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2022, we have requested the device be returned to the manufacturer.To date, we have not received the device.

Event Description

On (b)(6) 2022, the consumer claims her daughter was burned on the back of her arm.To date, medical attention was not received.

Manufacturer Narrative

5/09/2022: we have requested the device be returned to the manufacturer.To date, we have not received the device.08/08/2022: the device was returned to the manufacturer and the investigation was complete.Below is the manufacturers narrative: manufacturers narrative: sample was received on (b)(6) 2022 in a non-working condition.No testing was possible.Line cord was damaged.Product is 16 years old.Manufactured in 2006.Heating pads are handled roughly and need to be checked frequently prior to use to prevent problems.Our instructions clearly state to check often and do not use if cord or product is damaged.The unit received had a badly damaged cord that was the cause of the sparking and subsequent over heating.Pvc enclosure also had opened on the edges.Our ul safety testing has stringent power cord and enclosure seam testing which comply with.

Event Description

On (b)(6) 2022, the consumer claims her daughter was burned on the back of her arm.To date, medical attention was not received.

• 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: 14336421
• MDR Text Key: 291610294
• Report Number: 1222304-2022-00015
• Device Sequence Number: 1
• Product Code: IRT
• UDI-Device Identifier: 74108104670
• UDI-Public: 74108104670
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: HP15
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other