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

Model Number DNTL BR 4CT CA

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

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

Event Date 11/04/2016

Event Type  malfunction  

Event Description

The bristles on the wire wear off very quickly and within a few days the wire itself will break off.

• 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: 6099606
• MDR Text Key: 60360786
• Report Number: 1825660-2016-00042
• 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
• Type of Report: Initial
• Report Date: 11/07/2016

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: Device Unattended
• Device Model Number: DNTL BR 4CT CA
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/04/2016
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1