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

Model Number PKFL MM II 90

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

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

Event Date 10/14/2019

Event Type  malfunction  

Event Description

Consumer stated he had been using this product for many years, however, "this batch has a problem with the toothpick snapping causing a sharp edge at the bottom of the pick, sometimes the pick breaks off." left over pieces from the bag were returned, but no broken flossers.

• Brand Name: PLACKERS 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 49512 5353
• Manufacturer Contact: rebekah stenske ; 6166988880
• MDR Report Key: 9256737
• MDR Text Key: 175843639
• Report Number: 1825660-2019-00643
• 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: 10/30/2019

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 MM II 90
• Device Lot Number: 9028A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Distributor Facility Aware Date: 10/14/2019
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/30/2019
• 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