MAUDE Adverse Event Report: RANIR, LLC FLOSSER; FLOSSING DEVICE WITH TOOTHPICK END

Model Number FLOSSER

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Injury (2348)

Event Date 09/26/2014

Event Type  Injury  

Event Description

".Was poking them along my gums.A couple of the teeth broke off into my gum.Had to go to periodontist to have it removed.The teeth things irritate the gums".(at the initial report by consumer, it sounded as if his teeth broke off in the gum - hence, needing to see a periodontist.) after the device and medical records were requested and further discussion with consumer on (b)(6) 2014, it was determined that the flosser was misidentified by the consumer and this is a toothpick with tiny "teeth" on the end.The tiny teeth broke when the consumer pressed it into his gums.

• Brand Name: FLOSSER
• Type of Device: FLOSSING DEVICE WITH TOOTHPICK END
• Manufacturer (Section D): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer (Section G): RANIR, LLC; 4701 east paris avenue se; grand rapids MI 49512
• Manufacturer Contact: elsa baker ; 4701 east paris avenue se; grand rapids, MI 49512 ; 6166988880
• MDR Report Key: 4241395
• MDR Text Key: 5049447
• Report Number: 1825660-2014-00950
• 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: 11/10/2014

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: Dentist
• Device Model Number: FLOSSER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: 10/28/2014
• Initial Date FDA Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: No
• 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