MAUDE Adverse Event Report: RANIR LLC SMARTLY FLSS 78YD WX; FLOSS, DENTAL

Model Number FLSS 78YD WX

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Pain (1994); Swelling (2091)

Event Date 06/10/2019

Event Type  malfunction  

Event Description

Consumer stated "my husband and i used this (nylon waxed dental floss) last night and now both of us have swollen gums and painful teeth.It feels like there are fibers stuck between my teeth from the dental floss.I usually don't use this brand and have never had this kind of reaction before." reached out to the consumer and received no response.

• Brand Name: SMARTLY FLSS 78YD WX
• 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: 8894567
• MDR Text Key: 167638379
• Report Number: 1825660-2019-00594
• 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: 08/14/2019

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: FLSS 78YD WX
• Device Lot Number: 252791
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/19/2019
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/14/2019
• 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