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

Model Number PKFL HI PERF MNT 50 SRT DS

Device Problem Difficult to Remove (1528)

Patient Problem Tooth Fracture (2428)

Event Date 12/20/2016

Event Type  Injury  

Event Description

The floss got stuck between her teeth.She pulled/yanked on it and got it out.She realized that she had chipped a tooth.

• 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 5353
• Manufacturer Contact: rebekah stenske ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 6230878
• MDR Text Key: 64131374
• Report Number: 1825660-2017-00041
• 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: 12/20/2016

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: Device Unattended
• Device Model Number: PKFL HI PERF MNT 50 SRT DS
• Device Lot Number: 5352C(O)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/20/2016
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/06/2017
• Type of Device Usage: N
• Patient Sequence Number: 1