MAUDE Adverse Event Report: RANIRLLC UP&UP MNTB KDS SO 4PK; FLOSS, DENTAL

Model Number MNTB KDS SO 4PK

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2021

Event Type  malfunction  

Event Description

Consumer stated that their child used these tooth brushes and ended up with a mouth full of plastic.They thought it was just one but they tried 2 more and those fell apart as well.

• Brand Name: UP&UP MNTB KDS SO 4PK
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): RANIRLLC; 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 hamilton ; 6166988880
• MDR Report Key: 11850413
• MDR Text Key: 258685019
• Report Number: 1825660-2021-00953
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 71031266529
• UDI-Public: 71031266529
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB KDS SO 4PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/20/2021
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/19/2021
• 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