MAUDE Adverse Event Report: RANIR LLC EQUATE FLSR CLN MNT 75CT; FLOSS, DENTAL

Model Number FLSR CLN MNT 75CT

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Event Description

Consumer states: they break all the time.Has broken tips off the top, almost out.

• Brand Name: EQUATE FLSR CLN MNT 75CT
• 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: julia bowen ; 6166988880
• MDR Report Key: 13255419
• MDR Text Key: 287387901
• Report Number: 1825660-2022-01043
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 68113140293
• UDI-Public: 68113140293
• Combination Product (y/n): N
• 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: 01/13/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: FLSR CLN MNT 75CT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/18/2021
• Initial Date Manufacturer Received: 12/18/2021
• Initial Date FDA Received: 01/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1