MAUDE Adverse Event Report: RANIR LLC PLACKERS; FLOSS, DENTAL

Model Number PKFL MM II 90

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem Tooth Fracture (2428)

Event Date 07/24/2017

Event Type  Injury  

Event Description

She used the plackers micro mint flosser and she couldn't get it out of her teeth and it has pulled out her tooth.She tried it and it got stuck and she pulled it and it pulled her filling out.

• Brand Name: PLACKERS
• 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 ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 6807591
• MDR Text Key: 83146015
• Report Number: 1825660-2017-00136
• Device Sequence Number: 1
• Product Code: JES
• 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: Device Unattended
• Type of Report: Initial
• Report Date: 07/25/2017

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: Device Unattended
• Device Model Number: PKFL MM II 90
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/24/2017
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1