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

Model Number MICRO MINT

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2020

Event Type  malfunction  

Event Description

Consumer stated, "i have a complaint about your micro mint plackers.The fold away parts of the 2 bag i have gotten are broken or break off easily.Would like them replaced.".

• Brand Name: PLACKERS
• 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: 10671526
• MDR Text Key: 214152758
• Report Number: 1825660-2020-00822
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 00651080690515
• UDI-Public: 651080690515
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MICRO MINT
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/16/2020
• Date Manufacturer Received: 09/16/2020
• 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