MAUDE Adverse Event Report: RANIR LLC GENTLE SLIDE FLOSSER; DENTAL FLOSSER

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Swelling (2091)

Event Date 10/26/2015

Event Type  Injury  

Event Description

Consumer said when she uses the gentle slide flossers her gums swell.The area between her teeth gets puffy.They stop swelling after using them.

• Brand Name: GENTLE SLIDE FLOSSER
• Type of Device: DENTAL FLOSSER
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512 5353
• Manufacturer Contact: elsa baker ; 4701 east paris ave se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 5246275
• MDR Text Key: 32016627
• Report Number: 1825660-2015-00107
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2015

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: Device Unattended
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1