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

Model Number MNTB ORB BRIL WH OPT SO 2PK

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

Could not retrieve product as the consumer had thrown the toothbrush away.

Event Description

Customer is claiming the toothbrush is falling apart.Rubber bristles were falling out during use.

• 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: 6770236
• MDR Text Key: 82116465
• Report Number: 1825660-2017-00132
• Device Sequence Number: 1
• Product Code: EFW
• 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: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MNTB ORB BRIL WH OPT SO 2PK
• Device Lot Number: 97029
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/17/2017
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 08/07/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1