MAUDE Adverse Event Report: RANIR LLC UP&UP MNTB KDS SO 4PK; TOOTHBRUSH, MANUAL

Model Number MNTB KDS SO 4PK

Device Problems Detachment of Device or Device Component (2907); Inadequate User Interface (2958)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2020

Event Type  malfunction  

Event Description

Consumer stated "my kids chew their toothbrushes while brushing and these came apart.Choking hazard! this happened with 3 of the toothbrushes with my toddler (b)(6) and my older child (b)(6) using them each at about 2-3 weeks.I didn't chance it with the 4th toothbrush and i am sorry to say i do not have them to send to you.My kids chew on their toothbrushes quite a bit while brushing and with these toothbrushes the bristles were coming out by chunks as well.After the third brush we just switched back to a brand that is all hard plastic ((b)(6) kids toothbrushes).I am sorry i could not be of more help with this issue.Thank you for reaching out to us, that certainly means a lot!".

• Brand Name: UP&UP MNTB KDS SO 4PK
• 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: 10490646
• MDR Text Key: 208390191
• Report Number: 1825660-2020-00804
• Device Sequence Number: 1
• Product Code: EFW
• 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: Other
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• 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: 08/31/2020
• Date Manufacturer Received: 08/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1