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

Model Number	BR HDS SMSNC PRO ADV CLN 3PK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated the (b)(4) 3ct brush bristles are coming out while she brushes her teeth.It happened the 1st time she used the brush head and continued to happen.

• Brand Name: EQUATE BR HDS SMSNC PRO ADV CLN
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 10813457
• Report Number: 1825660-2020-00831
• Device Sequence Number: 11844471
• Product Code: JEQ
• UDI-Device Identifier: 00681131129053
• UDI-Public: 681131129053
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/09/2020

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 CLN 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2020
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1