MAUDE Adverse Event Report: RANIR LLC CVS MNTB ULT FRSH SO; TOOTHBRUSH, MANUAL

Model Number MNTB ULT FRSH SO 6PK

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Sensitivity of Teeth (2427)

Event Date 07/07/2020

Event Type  malfunction  

Event Description

Consumer stated that she was brushing her teeth and felt multiple bristles comes out and get stuck inbetween her teeth, when she pulled the bristles out using her fingers,she described it as tugging and tugging to get them out her crown then fell out.She has an appointment this weekend with her dentist.Consumer does not have the toothbrush.

• Brand Name: CVS MNTB ULT FRSH SO
• Type of Device: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer Contact: rebekah stenske ; 6166988880
• MDR Report Key: 10480220
• MDR Text Key: 208389016
• Report Number: 1825660-2020-00800
• Device Sequence Number: 1
• Product Code: EFW
• UDI-Device Identifier: 50428336731
• UDI-Public: 50428336731
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB ULT FRSH SO 6PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/04/2020
• Date Manufacturer Received: 08/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1