MAUDE Adverse Event Report: RANIR LLC SOLIMO BR HDS SMSNC PRO ADV NP 4PK; TOOTHBRUSH, POWERED

Model Number	BR HDS SMSNC PRO ADV NP 4PK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer posted on (b)(4): "i was disappointed in these brush heads.It was supposed to be enough for to last a whole year.To use each one for three months.The bristles would fall off and they would vibrate off of the unit" no further information provided.

• Brand Name: SOLIMO BR HDS SMSNC PRO ADV NP 4PK
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 10737669
• Report Number: 1825660-2020-00825
• Device Sequence Number: 11673823
• Product Code: JEQ
• UDI-Device Identifier: 00842379159190
• UDI-Public: 842379159190
• 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): 10/26/2020

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 4PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1