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

Model Number RTGX

Device Problem Loss of Power (1475)

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

Event Date 01/08/2022

Event Type  malfunction  

Event Description

6/15/2022 - the incident occurred on (b)(6) 2022 but were not notified until 6/8/2022.The consumer claims the device has no power and was taking enamel off the consumer's teeth.The consumer has either requested a refund or an exchange for a different product.

Manufacturer Narrative

07/06/2022 - we have requested the device be returned to the manufacturer for an investigation.To date, we have not received the device.

Manufacturer Narrative

On 07/06/2022, we have requested the device be returned to the manufacturer for an investigation.To date, we have not received the device.On 08/08/2022, we received the devices and the investigation is complete.Below is the manufacturers narrative.Manufacturers narrative: no testing possible.Unit not charging.Separate charger was used to charge the toothbrush and toothbrush worked as designed.Consumer malfunction was caused by defective charger.Electric toothbrushes are to be used with little pressure, manual toothbrushing uses much more force.The correct use allows the bristles to move in order to clean teeth.With any excessing gum or teeth discomfort, use should be discontinued per ib.A separate charger was used to charge the unit and unit performed as deigned.Malfunction related to the charger not working to recharge the unit.

Event Description

On 6/15/2022, the incident occurred on (b)(6) 2022 but were not notified until (b)(6) 2022.The consumer claims the device has no power and was taking enamel off the cosumers teeth.The consumer has either requested a refund or an exchange for a different product.

• 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: 14928224
• MDR Text Key: 303240278
• Report Number: 1222304-2022-00024
• 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,Followup
• Report Date: 07/06/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other