MAUDE Adverse Event Report: RANIR LLC PLACKERS PKFL MM II 90 3PK; FLOSS, DENTAL

Model Number PKFL MM II 90 3PK

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/25/2019

Event Type  malfunction  

Event Description

Consumer posted that they had used many of these flossers in the past and would save them for a few days to use more than once."this one breaks as soon as you fold it over to use the tooth pick end." no contact information provided; based on the description, it appears the folder over pick in the handle broke off.

• Brand Name: PLACKERS PKFL MM II 90 3PK
• 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: 9612333
• MDR Text Key: 184454299
• Report Number: 1825660-2020-00693
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• 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 90 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/25/2019
• Date Manufacturer Received: 12/25/2019
• 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