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

Model Number PKFL TWN LN 75/90

Device Problem Crack (1135)

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

Event Date 03/25/2020

Event Type  malfunction  

Event Description

Consumer stated he likes the product however a lot of the times that he folds out the toothpick, it simply cracks off.

• Brand Name: PLACKERS PKFL TWN LN
• 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: 9992659
• MDR Text Key: 190516480
• Report Number: 1825660-2020-00751
• 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: 04/23/2020

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 75/90
• Device Lot Number: 9353V
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/25/2020
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/23/2020
• 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