MAUDE Adverse Event Report: RANIR LLC EQUATE BR HDS EF FL VIP; TOOTHBRUSH, POWERED

Model Number	BR HDS EF FL VIP 3PK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated the eq tbp flseff rf 3ct falls out during use.Thanked the customer for taking the time to contact us and sharing his/her experience with the product.Called consumer, spoke to daughter; the bristles fell out, she didn't know if he still had them.Tufts coming out.Product not returned.

• Brand Name: EQUATE BR HDS EF FL VIP
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI
• MDR Report Key: 12170099
• Report Number: 1825660-2021-00979
• Device Sequence Number: 11132777
• Product Code: JEQ
• UDI-Device Identifier: 00681131129053
• UDI-Public: 681131129053
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: BR HDS EF FL VIP 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1