MAUDE Adverse Event Report: RANIR LLC SMARTLY MNTB BULLSEYE SO 2PK PNK; TOOTHBRUSH, MANUAL

Model Number MNTB BULLSEYE SO 2PK PNK

Device Problem Device Slipped (1584)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/16/2021

Event Type  malfunction  

Event Description

(b)(4) consumer stated: injury from toothbrush -cut mouth.Wrote: hello, i am very mad, i was brushing my teeth when a piece of the toothbrush came out, and with metal in it! it cut my mouth and it hurt really bad.This has happened 2 times now.I'm so mad.There was no contact information or product that was returned.

• Brand Name: SMARTLY MNTB BULLSEYE SO 2PK PNK
• Type of Device: TOOTHBRUSH, MANUAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave, se; grand rapids MI 49512 5353
• MDR Report Key: 12306830
• MDR Text Key: 267644711
• Report Number: 1825660-2021-00990
• Device Sequence Number: 1
• Product Code: EFW
• UDI-Device Identifier: 71031802833
• UDI-Public: 71031802833
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB BULLSEYE SO 2PK PNK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/26/2021
• Date Manufacturer Received: 07/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1