MAUDE Adverse Event Report: RANIR LLC PLACKERS PKFL TWN LN MNT; FLOSS, DENTAL

Model Number PKFL TWN LN MNT 75

Device Problem Use of Device Problem (1670)

Patient Problem Tooth Fracture (2428)

Event Date 05/22/2019

Event Type  malfunction  

Event Description

Consumer stated she "used the dental floss in center of my 2 front teeth and it took a good chunk out of one of them (left front incisor on upper teeth) in the back of tooth almost up to the gum.I used it right.She hopes it doesn't start aching and had a dental visit scheduled june 13th.

• Brand Name: PLACKERS PKFL TWN LN MNT
• 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: 8713742
• MDR Text Key: 149146744
• Report Number: 1825660-2019-00573
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/19/2019

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: Lay User/Patient
• Device Model Number: PKFL TWN LN MNT 75
• Device Lot Number: 8008A
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/22/2019
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/19/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1