MAUDE Adverse Event Report: RANIR LLC CVS MNTB SMTGRP CON SO 3PK; TOOTHBRUSH, MANUAL

Model Number MNTB SMTGRP CON SO 3PK

Device Problems Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)

Patient Problem No Information (3190)

Event Date 04/15/2019

Event Type  malfunction  

Event Description

Consumer stated she purchased 3 pack all pro tooth brushes head of brush is bending and bristle coming a loose, however she has had item over a month has used it before.

• Brand Name: CVS MNTB SMTGRP CON SO 3PK
• Type of Device: TOOTHBRUSH, MANUAL
• 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: rebekah stenske ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 8555245
• MDR Text Key: 143661166
• Report Number: 1825660-2019-00547
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• 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 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/16/2019
• Date Manufacturer Received: 04/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1