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

Model Number UNKNOWN PLACKERS FLOSSER

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Code Available (3191)

Event Date 12/01/2017

Event Type  Injury  

Event Description

Consumer stated the flosser broke her tooth and she is looking for reimbursement of the crown she had to have to fix.Problem occurred in (b)(6) of 2017; reported to her dentist and had it filled (b)(6) 2018 compliments of dentist, filling fell out, had it refilled (did not have the date handy).That filling fell out and was told she had to have a crown, could not afford one and would up going to the dental school and having it done.

• 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 ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 7898300
• MDR Text Key: 121042794
• Report Number: 1825660-2018-00418
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN PLACKERS FLOSSER
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/12/2018
• Date Manufacturer Received: 09/12/2018
• 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