MAUDE Adverse Event Report: RANIR LLC TARGET MNTB SMTGRP CONT SO/ME; TOOTHBRUSH, MANUAL

Model Number MNTB SMTGRP CONT SO/ME

Device Problems Product Quality Problem (1506); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2021

Event Type  malfunction  

Event Description

Guest contacted us related a toothbrush that he had purchased and the quality of the product is not good, the hairs are falling down and it's really annoying when he is brushing his teeth.

• Brand Name: TARGET MNTB SMTGRP CONT SO/ME
• Type of Device: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave, se; grand rapids MI 49512 5353
• MDR Report Key: 12432805
• MDR Text Key: 281755919
• Report Number: 1825660-2021-01001
• Device Sequence Number: 1
• Product Code: EFW
• UDI-Device Identifier: 71031337526
• UDI-Public: 71031337526
• 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 CONT SO/ME
• 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