MAUDE Adverse Event Report: RANIR LLC TWIN LINE; FLOSS, DENTAL

Model Number PKFL TWN LN MNT 160

Device Problem Difficult to Remove (1528)

Patient Problem Tooth Fracture (2428)

Event Date 09/02/2016

Event Type  Injury  

Manufacturer Narrative

No samples or lot number provided.The largest record average break strength in the last 2 years is 13.7 lbf, it is rare to see break strengths anything above 14 lbf.With no sample or lot number all conclusions will only be speculation.

Event Description

I was flossing my teeth two nights ago and, the floss got stuck.I was unable to remove and as i struggled to get it out, it broke a filled tooth off at the front of my mouth.

• Brand Name: TWIN LINE
• 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: brenda mumbower ; 6166988880
• MDR Report Key: 5989986
• MDR Text Key: 56014262
• Report Number: 1825660-2016-00018
• 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: 09/07/2016

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 TWN LN MNT 160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/02/2016
• Initial Date Manufacturer Received: 09/02/2016
• Initial Date FDA Received: 09/30/2016
• 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