MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; ELECTRIC TOOTHBRUSH

Model Number RTGX

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

Patient Problem Tooth Fracture (2428)

Event Date 07/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2021: we have requested the device be returned to the manufacturer.To date we have not received the device.

Event Description

(b)(6) 2021: the consumer claims to have broken a tooth while in use of the product.The consumer did not receive medical attention.

• Brand Name: CONAIR
• Type of Device: ELECTRIC TOOTHBRUSH
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford CT 06902
• MDR Report Key: 12511647
• MDR Text Key: 273769141
• Report Number: 1222304-2021-00022
• Device Sequence Number: 1
• Product Code: JEQ
• UDI-Device Identifier: 85452000105
• UDI-Public: 85452000105
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RTGX
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other