MAUDE Adverse Event Report: RANIR LLC TARGET MNTB SMTGRP CON SO 4PK; TOOTHBRUSH, MANUAL

Model Number MNTB SMTGRP CON SO 4PK

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2021

Event Type  malfunction  

Event Description

Guest states that he keeps getting cooper pieces every time he brushes his teeth with the tooth brush.Guest can send photos guest would like to know if they are coming from the tooth brush?.

• Brand Name: TARGET MNTB SMTGRP CON SO 4PK
• Type of Device: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave, se; grand rapids MI 49512 5353
• MDR Report Key: 12432877
• MDR Text Key: 271636681
• Report Number: 1825660-2021-01002
• Device Sequence Number: 1
• Product Code: EFW
• UDI-Device Identifier: 71031673624
• UDI-Public: 71031673624
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB SMTGRP CON SO 4PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/13/2021
• Date Manufacturer Received: 08/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1