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

Model Number RTGX

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/10/2023

Event Type  Injury  

Manufacturer Narrative

On 8/30/2023 - we have requested the device be returned to the manufacturer for an investigation.To date, we have not received the device.

Event Description

On (b)(6) 2023 - the consumer claim to have cut her lip and had bruising while in use of the product.Medical attention was not received.

• 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: 17682325
• MDR Text Key: 322620312
• Report Number: 1222304-2023-00020
• Device Sequence Number: 1
• Product Code: JEQ
• UDI-Device Identifier: 85452000105
• UDI-Public: 85452000105
• 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: 08/10/2023

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: RTGX
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other