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

Model Number	BR HDS SMSNC PRO ADV NP 3PK +1 HD
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated the blue bristles fell out of the brush head.She used it for 1 1/2 weeks.This is the first time she has purchased this product.Consumer returned the product to the store.Emailed cvs and requested product but was unable to retrieve the product.

• Brand Name: CVS BR HDS SMSNC PRO ADV NP
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512 5353
• MDR Report Key: 9832414
• Report Number: 1825660-2020-00732
• Device Sequence Number: 14311464
• Product Code: JEQ
• UDI-Device Identifier: 00050428348925
• UDI-Public: 050428348925
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/13/2020

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 +1 HD
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1