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

Model Number PKFL MM II 150

Device Problems Product Quality Problem (1506); Structural Problem (2506)

Patient Problem Sensitivity of Teeth (2427)

Event Date 05/20/2020

Event Type  malfunction  

Event Description

Consumer posted a review on (b)(6) stating: "this product do have nice mint and slightly sweet flavor.What i don't like is that the thread is too tough and thin.I have filling between two teeth.When i floss that spot, it first stuck and than remove the filling when i force it out.Although my dentist should share some responsibility, but i never have that problem using others (flat and wide thread)." no contact information provided.

• Brand Name: PLACKERS PKFL MM II
• 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: 10228148
• MDR Text Key: 198748472
• Report Number: 1825660-2020-00779
• 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: Other
• Type of Report: Initial
• Report Date: 07/02/2020

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: PKFL MM II 150
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/03/2020
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 07/03/2020
• 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