MAUDE Adverse Event Report: RANIR LLC EQUATE FLSR CLN MNT; FLOSS, DENTAL

Model Number FLSR CLN MNT 75CT

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/08/2021

Event Type  malfunction  

Event Description

Consumer stated the cln mnt 75ct snaps off during use causing it to get stuck in customers teeth.Contacted consumer: she used all the time.The end of the pick broke off in her teeth.One that broke was in there for 3 days, and she was able to get it out.Threw them out.All of them, ends were snapping off in her teeth *no product being returned.

• Brand Name: EQUATE FLSR CLN MNT
• Type of Device: FLOSS, DENTAL
• 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: 11793272
• MDR Text Key: 258685962
• Report Number: 1825660-2021-00943
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 68113140293
• UDI-Public: 68113140293
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FLSR CLN MNT 75CT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/09/2021
• Date Manufacturer Received: 04/09/2021
• 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