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

Model Number PKFL WH RA MNT 75CT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 04/28/2017

Event Type  Injury  

Event Description

The flossing tool, plackers right angle, chipped his tooth.

• 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: 6585960
• MDR Text Key: 75792778
• Report Number: 1825660-2017-00090
• 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: Device Unattended
• Type of Report: Initial
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Device Model Number: PKFL WH RA MNT 75CT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/28/2017
• Date Manufacturer Received: 04/28/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1