MAUDE Adverse Event Report: RANIR LLC PLACKERS PKFL TWN LN 35; FLOSS, DENTAL

Model Number PKFL TWN LN 35

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tooth Fracture (2428)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Consumer stated: i picked up a twin line pack by accident but started to use them.At first they seem to be more effective at cleaning between teeth.But yesterday the line hooked on to my front tooth and shattered it in half.This product basically hooked on to an imperfection in my tooth and split my tooth in half.Not to be funny since i live in (b)(6) but my tooth looks like that building that collapsed here in (b)(6) half of my tooth is standing the front half is missing.I have scheduled an emergency dental appointment today with my dentist.I have never experienced such a thing much less had any tooth damage previously.Growing up i never had cavities my teeth have always been solid and this absolutely brought me to tears.

• Brand Name: PLACKERS PKFL TWN LN 35
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 12233352
• MDR Text Key: 263818029
• Report Number: 1825660-2021-00985
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 5108036651
• UDI-Public: 5108036651
• 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: 07/27/2021

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: PKFL TWN LN 35
• Device Lot Number: 7310A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/02/2021
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/27/2021
• 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