MAUDE Adverse Event Report: RANIR LLC SOLIMO MNTB CLN+ SO; TOOTHBRUSH, MANUAL

Model Number MNTB CLN+ SO 10PK

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 05/09/2021

Event Type  malfunction  

Event Description

Review posted on amazon: "they were way overly soft-bristled.The bristles fell out, as well.I'm now using them for cleaning under faucets." no contact info provided or product returned.

• Brand Name: SOLIMO MNTB CLN+ SO
• Type of Device: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 11930244
• MDR Text Key: 258684405
• Report Number: 1825660-2021-00963
• Device Sequence Number: 1
• Product Code: EFW
• UDI-Device Identifier: 4237914687
• UDI-Public: 4237914687
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB CLN+ SO 10PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/09/2021
• Date Manufacturer Received: 05/09/2021
• 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