MAUDE Adverse Event Report: RANIR LLC UP&UP BR HDS SMSNC PRO ADV; TOOTHBRUSH, POWERED

Model Number	BR HDS SMSNC PRO ADV NP 3PK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated "just bought today and she used them, and the very sharp green bristles fell out.Very sharp and one stuck in her gums." she was able to pull it out.No injury but feels it could have been very dangerous to a child.Product not returned.

• Brand Name: UP&UP BR HDS SMSNC PRO ADV
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 10540592
• Report Number: 1825660-2020-00812
• Device Sequence Number: 3580802
• Product Code: JEQ
• UDI-Device Identifier: 00050428348925
• UDI-Public: 050428348925
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: BR HDS SMSNC PRO ADV NP 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1