MAUDE Adverse Event Report: RANIR LLC PLACKERS PKFL MM II 90; FLOSS, DENTAL

Model Number PKFL MM II 90 3PK

Device Problems Break (1069); Sharp Edges (4013)

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

Event Date 08/08/2020

Event Type  malfunction  

Event Description

Consumer posted review on (b)(6): "when folded over to use the pick, the hinge exposes sharp edges and easily breaks, which make it difficult to use both the flosser and pick." no contact information, no product returned.

• Brand Name: PLACKERS PKFL MM II 90
• 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: 10485238
• MDR Text Key: 208389152
• Report Number: 1825660-2020-00801
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 00651080813501
• UDI-Public: 651080813501
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PKFL MM II 90 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/10/2020
• Date Manufacturer Received: 08/10/2020
• 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