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

Model Number PKFL MM II 90

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

Product was not returned and no lot number was provided.

Event Description

Consumer stated: i am highly allergic to sulfa and also have an allergy to artificial sweeteners.I am needing to know the ingredients in the micro mint flossers as i have begun to notice some signs of allergic reaction after using them.I saw that you use sucralose which usually doesn't affect me, so i am needing to find out if there are any other ingredients in them that might be causing these reactions." consumer didn't respond with further information.

• Brand Name: PLACKERS
• 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: 7553477
• MDR Text Key: 109762065
• Report Number: 1825660-2018-00333
• 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
• Type of Report: Initial
• Report Date: 05/30/2018

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: PKFL MM II 90
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/03/2018
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/30/2018
• 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