MAUDE Adverse Event Report: KROGER / RANIR, LLC. KROGER EASYFLEX TOTAL POWER; TOOTHBRUSH, POWERED

Device Problems Detachment of Device or Device Component (2907); Mechanical Jam (2983)

Patient Problem Laceration(s) (1946)

Event Date 11/06/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, the consumer stated that the product does not attach properly to the oral b toothbrush.When he was brushing his tongue, the attachment popped off and jammed his tongue.The consumer got a cut on his tongue but no medical attention was required.Purchase date: (b)(6) 2019, this date is an estimate.(b)(4).

• Brand Name: KROGER EASYFLEX TOTAL POWER
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): KROGER / RANIR, LLC.
• MDR Report Key: 9354193
• MDR Text Key: 167587389
• Report Number: MW5091221
• Device Sequence Number: 1
• Product Code: JEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1