MAUDE Adverse Event Report: RANIR LLC PLACKERS MICRO MINT; FLOSS

Device Problem Improper Chemical Reaction (2952)

Patient Problem Inflammation (1932)

Event Date 05/13/2015

Event Type  Injury  

Event Description

After using the product my husband developed a red inflammation on his gums.The periodontist treated it with steroids but it did not clear up.Now he has to have a biopsy done (to determine if it is cancerous).Is there some kind of chemical in the floss that is allowed in (b)(6) but not here?".

• Brand Name: PLACKERS MICRO MINT
• Type of Device: FLOSS
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer Contact: elsa baker ; 4701 east paris ave se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 4838669
• MDR Text Key: 5868363
• Report Number: 1825660-2015-00053
• 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: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 06/10/2015

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?: No
• Device Operator: Other
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1