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 Insufficient Information (4580)

Event Date 04/20/2021

Event Type  malfunction  

Event Description

Consumer called into store because she had two packages of the equate dental floss that broke at the end where the pick is.The pick is breaking off in her teeth with every flosser in both bags.

• 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: rebekah hamilton ; 6166988880
• MDR Report Key: 11851087
• MDR Text Key: 258684880
• Report Number: 1825660-2021-00956
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• 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
• Device Lot Number: 1012G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Distributor Facility Aware Date: 04/21/2021
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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