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

Model Number PKFL TWN LN MNT 150

Device Problem Entrapment of Device (1212)

Patient Problems Tooth Fracture (2428); Device Embedded In Tissue or Plaque (3165)

Event Date 04/16/2021

Event Type  Injury  

Event Description

Review received on (b)(6): "seems like they are only good for people who have gaps between the teeth! if your teeth are within normal proximity to each other, this floss gets stuck and won't come out.Never had this issue before with any floss! a family member pulled out his crown trying to floss with these!!!" no contact information provided.

• Brand Name: PLACKERS PKFL TWN LN 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: 11859642
• MDR Text Key: 262253602
• Report Number: 1825660-2021-00959
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 00703570156107
• UDI-Public: 703570156107
• 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: 05/20/2021

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 MNT 150
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/23/2021
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/20/2021
• 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