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

Model Number UNKNOWN FLOSSER

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/28/2021

Event Type  Injury  

Event Description

The consumer stated: these new green ones are a serious threat to my dental health.They shred like crazy and get stuck and i think i even just took away a small piece of tooth getting the one out just now.

• Brand Name: PLACKERS BACK TEETH MM
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512 5353
• MDR Report Key: 12704602
• MDR Text Key: 278630674
• Report Number: 1825660-2021-01019
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 5108059451
• UDI-Public: 5108059451
• 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: 10/27/2021

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: UNKNOWN FLOSSER
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/28/2021
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1