MAUDE Adverse Event Report: RANIR LLC PLACKERS PKFL HI PERF MNT; FLOSS, DENTAL

Model Number PKFL HI PERF MNT 60 CA

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/31/2019

Event Type  Injury  

Event Description

Consumer stated while she was "using the pick side on my bottom teeth (which has a permanent retainer) , i thought i had broken the flosser as it felt like i had bent it.Ultimately, what happened is the flosser popped off the retainer." consumer went to her orthodontist and he said she required "new molds and retainer to the cost of $700! insurance does not cover this cost as it's required "cosmetic" by the state of (b)(6)." reached out to the consumer and was unable to make contact.Didn't receive product.

• Brand Name: PLACKERS PKFL HI PERF 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: 8920937
• MDR Text Key: 155212346
• Report Number: 1825660-2019-00602
• 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: 08/22/2019

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 HI PERF MNT 60 CA
• Device Lot Number: 9015D
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/31/2019
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/22/2019
• 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