MAUDE Adverse Event Report: RANIR LLC PLACKERS PKFL TWN LN MNT 150; FLOSS, DENTAL

Model Number PKFL TWN LN MNT 150

Device Problem Material Integrity Problem (2978)

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

Event Date 12/02/2019

Event Type  malfunction  

Event Description

Consumer stated he had used plackers for many years.When he bends the handle back to expose the pick, it snaps off where it bends.Only happened when they went to bend it, not while they were using it.The same thing happened with him and his wife.No longer has the product, wife threw them out.

• Brand Name: PLACKERS PKFL TWN LN MNT 150
• 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 ; 6166988880
• MDR Report Key: 9532602
• MDR Text Key: 178751353
• Report Number: 1825660-2019-00683
• 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: 12/30/2019

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: PKFL TWN LN MNT 150
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/02/2019
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/30/2019
• 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