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

Model Number DSPL PDQ PKFL 9PC 750CT MLTI PK

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/24/2020

Event Type  malfunction  

Event Description

Consumer originally left a voicemail: "purchased at (b)(4), pk of 700 odd pieces.He was using them and it damaged one of the fillings in his tooth." returned his call and he called back same day.He was using them and that stuff sticks to your teeth and it seems to pull everything out of your teeth including fillings.I'm currently waiting to see the dentist as we speak.As soon as you put the floss between your teeth, it gets stuck there.This is the first time this kind of thing has ever happened to me.First time using this brand.(when asked if the floss malfunctioned in any way, he said, you could say that but he didn't indicate that the floss shredded or broke).Asked him if the flosser got stuck between his teeth and that's why he had to pull it out and he said yes, it got stuck between his teeth and so he had to pull the flosser out.

• Brand Name: PLACKERS MICRO MINT
• 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 ; 6166988880
• MDR Report Key: 10706620
• MDR Text Key: 214800572
• Report Number: 1825660-2020-00824
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 00651080177511
• UDI-Public: 651080177511
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/20/2020

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: DSPL PDQ PKFL 9PC 750CT MLTI PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/24/2020
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/20/2020
• 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