MAUDE Adverse Event Report: RANIR LLC CARE ONE; TOOTHBRUSH, MANUAL

Model Number INTRDNTL BR RA 16CT

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Code Available (3191)

Event Date 01/22/2018

Event Type  malfunction  

Event Description

Consumer originally stated the bristle(s) are coming off and you can't put them back in.Upon further information gathered, the consumer stated she started to use it and then the brush fell out, on 2 or 3 of them.The whole little brush that you stick in between.Consumer threw out the brushes.

• Brand Name: CARE ONE
• 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: 7232462
• MDR Text Key: 98997252
• Report Number: 1825660-2017-00234
• 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: 01/31/2018

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: Lay User/Patient
• Device Model Number: INTRDNTL BR RA 16CT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/22/2018
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 01/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1