MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR CORPORATION; ELECTRIC TOOTHBRUSH

Model Number RTGX

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Tissue Damage (2104)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2020 - we have requested the device be returned to the manufacturer for evaluation.To date, we have not received the device.

Event Description

(b)(6) 2020 - the consumer claims that the brush head on the product came off and scratched the roof of her mouth.Medical attention was not received.

• Brand Name: CONAIR CORPORATION
• Type of Device: ELECTRIC TOOTHBRUSH
• Manufacturer (Section D): CONAIR CORPORATION; 1 cummings point rd.; stamford,
• Manufacturer Contact: 1 cummings point rd.; stamford,
• MDR Report Key: 10051272
• MDR Text Key: 200383543
• Report Number: 1222304-2020-00006
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• 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
• 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
• Patient Age: 50 YR