MAUDE Adverse Event Report: RANIR LLC EQUATE; TOOTHBRUSH, MANUAL

Model Number MNTB ORB BRIL WH OPT SO 2PK

Device Problem Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/15/2018

Event Type  malfunction  

Event Description

This is the fourth time customer has purchased this product and when using it all the bristles came out while brushing teeth; and they have been really close to swallowing bristles and/or hurting themselves.On the second day of use, the rubber pieces fell out.He swallowed at least one piece.

• Brand Name: EQUATE
• 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: 7429438
• MDR Text Key: 105661406
• Report Number: 1825660-2017-00281
• 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: Patient
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB ORB BRIL WH OPT SO 2PK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/16/2018
• Date Manufacturer Received: 03/16/2018
• 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