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

Model Number PKFL MM II 90

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/02/2016

Event Type  No Answer Provided  

Event Description

I was flossing my teeth and it broke between my teeth, a piece.

• Brand Name: PLACKERS
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512
• Manufacturer (Section G): RANIR LLC; 4701; east paris ave se; grand rapids MI 49512
• Manufacturer Contact: brenda mumbower ; 4701 east paris ave se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 6063542
• MDR Text Key: 58654086
• Report Number: 1825660-2016-00036
• 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: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• 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
• Distributor Facility Aware Date: 10/02/2016
• Date Manufacturer Received: 10/02/2016
• Type of Device Usage: Initial
• Patient Sequence Number: 1