MAUDE Adverse Event Report: RANIR LLC PLACKERS PKFL MM II 150CT; FLOSS, DENTAL

Model Number PKFL MM II 150CT

Device Problem Human-Device Interface Problem (2949)

Patient Problem Tooth Fracture (2428)

Event Date 03/09/2021

Event Type  malfunction  

Event Description

Consumer stated: "i am using your dental flossers already for fer months.Just finished installing a crown for a tooth which broke off after using your flossers.After it broke off, thought that's my tooth was broken, but after installing a crown my dentist checked my teeth with x-ray and did not find any additional problems.Now the interesting part starts! while using your flossers, my second tooth broke off.And it is huge one.I am sending you pictures of the broken tooth and a package picture.Tomorrow i will go to my dentist for his professional opinion and if he will confirm that tooth was not cracked, i am filing a lawsuit." no product returned.

• Brand Name: PLACKERS PKFL MM II 150CT
• 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 hamilton ; 6166988880
• MDR Report Key: 11623052
• MDR Text Key: 246424812
• Report Number: 1825660-2021-00931
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 00651080186513
• UDI-Public: 651080186513
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PKFL MM II 150CT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/09/2021
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 04/06/2021
• 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