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

Model Number PKFL TWN LN MNT 150

Device Problem Break (1069)

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

Event Date 01/30/2019

Event Type  malfunction  

Event Description

Consumer stated he/she had been a long time user of plackers twin line flossers she recently purchased a new pack at (b)(6) and immediately noticed that the plastic material used is different."it¿s stiff and less pliable and when flip down the toothpick it often breaks off as the material doesn't bend well.Right off i noticed hearing/feeling a ¿snap¿ like breaking noise on the first bend ¿ then after 2 or 3 bends it often breaks off on one or both sides ¿ this is not something i experienced in prior years of using and can say it almost never became detached.".

• 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: 8368329
• MDR Text Key: 138090766
• Report Number: 1825660-2019-00508
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PKFL TWN LN MNT 150
• Device Lot Number: 8197A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Distributor Facility Aware Date: 01/30/2019
• Date Manufacturer Received: 01/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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