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

Model Number BM1RLF

Device Problem Smoking (1585)

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

Event Date 03/23/2024

Event Type  malfunction  

Event Description

(b)(6) 2024 - the consumer claims the unit was smoking and the plastic on the unit was very hot.The unit has a 1 year warrenty.The consumer returned the product and accepeted a replacement.

Manufacturer Narrative

(b)(6) 2024 - the product has a 1 year warrenty.Therefore, the consumer accepted a replacement and an investigation will not occur.

• 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.; stratford, CT 06902
• MDR Report Key: 19151704
• MDR Text Key: 341565748
• Report Number: 1222304-2024-00010
• Device Sequence Number: 1
• Product Code: ISA
• 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
• Report Date: 04/22/2024

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: BM1RLF
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other