MAUDE Adverse Event Report: RANIR LLC TOPCARE FLSS 100YD UNWX; FLOSS, DENTAL

Model Number FLSS 100YD UNWX CD

Device Problem Material Frayed (1262)

Patient Problem No Code Available (3191)

Event Date 11/17/2019

Event Type  Injury  

Event Description

Consumer stated "first off it¿s impossible to pull out between your teeth and then it loosened my dental crown.You can tell just by looking at it it¿s low quality it gets frayed after one tooth.Now i will need to pay to recement my crown for around (b)(6)." reached out to consumer and she didn't respond, product was not returned for review.

• Brand Name: TOPCARE FLSS 100YD UNWX
• 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: 9507035
• MDR Text Key: 175840016
• Report Number: 1825660-2019-00678
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FLSS 100YD UNWX CD
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/26/2019
• Date Manufacturer Received: 11/26/2019
• 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