MAUDE Adverse Event Report: RANIR LLC SHYN SMSNC PRO GUM CARE; TOOTHBRUSH, POWERED

Model Number SMSNC PRO GUM CARE SHYN BULK BLK

Device Problem Material Fragmentation (1261)

Patient Problem Swelling (2091)

Event Date 07/15/2020

Event Type  malfunction  

Event Description

Consumer emailed stating that "the last 3 toothbrush heads i have received have all had bristles start to come out as i am brushing my teeth.I just put in a new one a week ago and bristles are already coming off in my mouth." product not returned.

• Brand Name: SHYN SMSNC PRO GUM CARE
• 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: 10385630
• MDR Text Key: 204414645
• Report Number: 1825660-2020-00789
• Device Sequence Number: 1
• Product Code: JEQ
• UDI-Device Identifier: 00850003700250
• UDI-Public: 850003700250
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SMSNC PRO GUM CARE SHYN BULK BLK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/15/2020
• Date Manufacturer Received: 07/15/2020
• 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