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 05/22/2023

Event Type  Injury  

Manufacturer Narrative

05/31/2023 - we have requested the device be returned to the manufacturer for an investigation.To date, we have not received the device.

Event Description

(b)(6) 2023- the consumer claims the device hurt his hand while trying to replace the brush head.The brush head slipped when trying to get the brush on the metal shaft and went thru his palm.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: 17029702
• MDR Text Key: 316379980
• Report Number: 1222304-2023-00015
• 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: 05/31/2023

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: 05/31/2023
• 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