MAUDE Adverse Event Report: RANIR LLC PLACKERS MM II TRVL 12; FLOSS, DENTAL

Model Number PKFL MM II TRVL 12

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Sensitivity of Teeth (2427)

Event Date 11/06/2019

Event Type  malfunction  

Event Description

Consumer stated he or she "popped the crown right off my tooth with these flossers.I'm sure it was user error but i think i'll stick with dental floss." no contact information provided to gather more info.

• Brand Name: PLACKERS MM II TRVL 12
• 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: 9379044
• MDR Text Key: 175841197
• Report Number: 1825660-2019-00663
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PKFL MM II TRVL 12
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/06/2019
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/26/2019
• 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