MAUDE Adverse Event Report: RANIR LLC SHYN SMSNC PRO ADV CLN; TOOTHBRUSH, POWERED

Model Number SMSNC PRO ADV CLN ASY SHYN BULK WHT

Device Problem Material Fragmentation (1261)

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

Event Date 11/26/2019

Event Type  malfunction  

Event Description

Consumer stated he/she "used the brush for two days now.My concern is that every time i've brushed, i end up with a stray bristle in my mouth.The first brushing was the worst- a mouthful of loose bristle- but i'm still experiencing a few in my mouth each time." requested the product back but it was not returned.

• Brand Name: SHYN SMSNC PRO ADV CLN
• Type of Device: TOOTHBRUSH, POWERED
• 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 ; 6166988880
• MDR Report Key: 9507106
• MDR Text Key: 178751362
• Report Number: 1825660-2019-00679
• Device Sequence Number: 1
• Product Code: JEQ
• 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: 12/20/2019

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: SMSNC PRO ADV CLN ASY SHYN BULK WHT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/26/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/20/2019
• 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