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

Model Number PKFL GS MNT 110

Device Problems Patient-Device Incompatibility (2682); Device Markings/Labelling Problem (2911)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/03/2018

Event Type  malfunction  

Event Description

Consumer asked if the placker gentle slide is flavored with mint.She stated she is allergic to artificial sweeteners and she thought she tasted some on the flosser.Consumer emailed back stating that we should have ingredients on the packages for allergy reasons as she had an allergic reaction to the floss.

• Brand Name: PLACKERS PKFL GS MNT
• 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: 7964861
• MDR Text Key: 125320618
• Report Number: 1825660-2018-00434
• Device Sequence Number: 0
• Product Code: JES
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PKFL GS MNT 110
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/03/2018
• Initial Date Manufacturer Received: 10/03/2018
• Initial Date FDA Received: 10/15/2018
• 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