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

Model Number SMSNC PRO GUM CARE SHYN BULK BLK

Device Problem Device Slipped (1584)

Patient Problem Increased Appetite (4570)

Event Date 12/21/2020

Event Type  malfunction  

Event Description

Consumer stated: i just received my replacement heads and when i brushed the bristles are falling out.

• Brand Name: SHYN SMSNC PRO GUM CARE SHYN
• 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 hamilton ; 6166988880
• MDR Report Key: 11204169
• MDR Text Key: 228910076
• Report Number: 1825660-2021-00896
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• 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: 12/23/2020
• Date Manufacturer Received: 12/23/2020
• 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