MAUDE Adverse Event Report: RANIR LLC WALGREENS FLSP SENS 90CT; FLOSS, DENTAL

Model Number FLSP SENS 90CT

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2019

Event Type  malfunction  

Event Description

Consumer bought a bag of flossers that did not indicate that it was mint flavored on the packaged and the consumer tasted mint.Consumer was wondering if the flossers were meant to be mint.Confirmed with the consumer that the flossers were manufactured with mint.The product the consumer used was not returned.The package labeling was corrected.

• Brand Name: WALGREENS FLSP SENS 90CT
• 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: 8713803
• MDR Text Key: 149146796
• Report Number: 1825660-2019-00574
• 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
• Type of Report: Initial
• Report Date: 06/19/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FLSP SENS 90CT
• Device Lot Number: 8045B
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/30/2019
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/19/2019
• 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