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

Model Number SMSNC PRO PLAT CLN II SHYN BULK WHT

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/28/2020

Event Type  malfunction  

Event Description

Consumer stated "i stared using a new brush head and everytime i brush, i end up with a few bristles in my mouth.".

• Brand Name: SHYN SMSNC PRO PLAT CLN II
• 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: 10437467
• MDR Text Key: 204523237
• Report Number: 1825660-2020-00796
• Device Sequence Number: 1
• Product Code: JEQ
• UDI-Device Identifier: 00850003700854
• UDI-Public: 850003700854
• 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: 08/21/2020

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 PLAT CLN II SHYN BULK WHT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/28/2020
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/21/2020
• 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