MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; HEATING PAD

Model Number HP01XF

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

On 09/22/2021 - we requested the device be returned to the manufacturer.To date, we have not received the device.

Event Description

On (b)(6) 2021 - the consumer claims the product burnt his sheet, blanket and couch.Injuries did not occur.

Event Description

On (b)(6) 2021: the consumer claims the product burnt his sheet, blanket and couch.Injuries did not occur.

Manufacturer Narrative

09/22/2021: we requested the device be returned to the manufacturer.To date, we have not received the device.2/23/2022: the consumer returned the device and the investigation is complete.Below is the manufacturers narrative: the unit was abused.Crease lines show it was heated in a folded position, not used as instructed - to lay flat over surface to be treated.Cord exit had shorted and burned and should be inspected prior to use.The edge of the pad was opened to expose interior padding.Unit yellowed and had overheated.Unit was used in a folded position and was covered by additional fabrics.Unit should have been discarded due to the controller cord short and strain relief opening.

• 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: 12511714
• MDR Text Key: 273748007
• Report Number: 1222304-2021-00025
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HP01XF
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1