MAUDE Adverse Event Report: RANIR LLC EQUATE BR HDS SMSNC PRO ADV NP 3PK; TOOTHBRUSH, POWERED

Model Number BR HDS SMSNC PRO ADV NP 3PK

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2021

Event Type  malfunction  

Event Description

The bristles are too hard and shed in your mouth.

• Brand Name: EQUATE BR HDS SMSNC PRO ADV NP 3PK
• Type of Device: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• Manufacturer Contact: julia bowen ; 1616988808
• MDR Report Key: 12989645
• MDR Text Key: 283815997
• Report Number: 1825660-2021-01029
• Device Sequence Number: 1
• Product Code: JEQ
• UDI-Device Identifier: 1373381567
• UDI-Public: 1373381567
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BR HDS SMSNC PRO ADV NP 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/15/2021
• Date Manufacturer Received: 11/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1