MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR; ELECTRIC TOOTHBRUSH

Model Number RTGX

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Laceration(s) (1946)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

On 07/07/2021 - our customer service department left the consumer a voice mail in order to file a claim.The consumer did not respond.Therefore we will have to wait until the consumer responds in order to request the device and perform and investigation.

Event Description

On 7/7/2021 - the consumer claims the product cut her mouth.The consumer submitted this claim on a recorded line.Our cs depart left the consumer a voice mail.However the consumer didn't respond.

Event Description

On (b)(6) 2021 - the consumer claims the product cut her mouth.The consumer submitted this claim on a recorded line.Our cs depart left the consumer a voice mail.However the consumer didn't respond.

Manufacturer Narrative

On 0707/2021 - our customer service department left the consumer a voice mail in order to file a claim.The consumer did not respond.Therefore we will have to wait until the consumer responds inorder to request the device and perform and investigation.On 7/12/2021 - the consumer responded on (b)(6) 2021.Per the consumer, this was a miscommunication as the device did not cause the cut in the consumers mouth.The consumer stated that she was having issues with her mouth.Below is the correspondence from our customer service department: rtgx// 3519xb// cx returning call about claim// cx states that it was a miscommunication that it did not actually cut her mouth she changed it right before it could and that she was already having other issues in her mouth.

• Brand Name: CONAIR
• Type of Device: ELECTRIC TOOTHBRUSH
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford CT 06902
• MDR Report Key: 12129068
• MDR Text Key: 260430629
• Report Number: 1222304-2021-00020
• 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,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: RTGX
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1