MAUDE Adverse Event Report: CONAIR LLC. CONAIR; ELECTRIC TOOTHBRUSH

Model Number RTGX01

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/23/2023

Event Type  malfunction  

Manufacturer Narrative

10/04/2023 - the consumer accepted a replacement will not be returned the device the manufacturer.Therefore, an investigation will not occur.

Event Description

9/25/2023 - the consumer claims the product had a burning smell.The consumer accepted a replacement.

• Brand Name: CONAIR
• Type of Device: ELECTRIC TOOTHBRUSH
• Manufacturer (Section D): CONAIR LLC.; 1 cummings point rd.; stamford CT 06902
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902
• MDR Report Key: 17867389
• MDR Text Key: 324873527
• Report Number: 1222304-2023-00022
• Device Sequence Number: 1
• Product Code: JEQ
• 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: 10/04/2023

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: RTGX01
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2023
• 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