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

Model Number FLSS 55YD UNWX CD

Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2017

Event Type  Injury  

Event Description

Customer is alleging the product caused crown to fall out.She put the floss between her teeth and it got stuck, so she thought she should pull a little harder and it popped her crown off.

• Brand Name: PUBLIX
• 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: 6485809
• MDR Text Key: 72550344
• Report Number: 1825660-2017-00075
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Device Unattended
• Type of Report: Initial
• Report Date: 03/17/2017

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?: Yes
• Device Operator: Device Unattended
• Device Model Number: FLSS 55YD UNWX CD
• Device Lot Number: 162757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/15/2017
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 04/12/2017
• Type of Device Usage: Unknown
• Patient Sequence Number: 1