MAUDE Adverse Event Report: RANIR LLC SOLIMO PWTB SMSNC PRO ADV CLN HNDL; TOOTHBRUSH, POWERED

Model Number	PWTB SMSNC PRO ADV CLN HNDL
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint came in on (b)(6), "worst electric toothbrush ive ever owned.The bristles broke off and got stuck in my gums.Very poor quality." no product returned, no contact info provided.

• Brand Name: SOLIMO PWTB SMSNC PRO ADV CLN HNDL
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 10891170
• Report Number: 1825660-2020-00851
• Device Sequence Number: 2644413
• Product Code: JEQ
• UDI-Device Identifier: 00842379159190
• UDI-Public: 842379159190
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: PWTB SMSNC PRO ADV CLN HNDL
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1