MAUDE Adverse Event Report: RANIR LLC KROGER FLSP CMPCT MNT HT; FLOSS, DENTAL

Model Number FLSP CMPCT MNT HT 150

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Tooth Fracture (2428)

Event Date 11/06/2020

Event Type  Injury  

Event Description

Consumer stated: has been using the flossers for a while.Was using the flossers yesterday around 2pm after eating.The flosser got stuck between teeth and chipped a tooth when getting the flosser unstuck.

• Brand Name: KROGER FLSP CMPCT MNT HT
• 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 stenske ; 6166988880
• MDR Report Key: 10898574
• MDR Text Key: 218224387
• Report Number: 1825660-2020-00856
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 4126037688
• UDI-Public: 4126037688
• 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: Other
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FLSP CMPCT MNT HT 150
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/06/2020
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/24/2020
• 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