MAUDE Adverse Event Report: RANIR LLC SMARTLY MNTB BULLSEYE SO; TOOTHBRUSH, MANUAL

Model Number MNTB BULLSEYE SO 2PK PNK

Device Problem Material Disintegration (1177)

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

Event Date 04/16/2019

Event Type  malfunction  

Event Description

Consumer stated he/she was brushing his/her teeth and the bristles "just fell off and into my mouth." product was not returned for review.

• Brand Name: SMARTLY MNTB BULLSEYE SO
• 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: 8654176
• MDR Text Key: 147077041
• Report Number: 1825660-2019-00570
• 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: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB BULLSEYE SO 2PK PNK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/16/2019
• Date Manufacturer Received: 05/16/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1