MAUDE Adverse Event Report: RANIR LLC EQUATE ESBTWN INTRDNTL SO PICK W/TRVL; TOOTHBRUSH, MANUAL

Model Number ESBTWN INTRDNTL SO PICK W/TRVL 50CT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/06/2020

Event Type  malfunction  

Event Description

Consumer stated eq flsbr esbtn 50ct broke the crown of the tooth inside which is the down front teeth.Contacted consumer and he said this was his first time using the product.This event happened with the first brush he used.He sees the dentist every 2-months as he has a good dental plan.Requested we pay for his dental bills to have the crown repaired.Product not returned.

• Brand Name: EQUATE ESBTWN INTRDNTL SO PICK W/TRVL
• 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 ; 6166988880
• MDR Report Key: 9654884
• MDR Text Key: 184455183
• Report Number: 1825660-2020-00699
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ESBTWN INTRDNTL SO PICK W/TRVL 50CT
• Device Lot Number: 9099B
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/07/2020
• Date Manufacturer Received: 01/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1