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

Model Number PKFL MM II 90

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Reaction (2414); Numbness (2415)

Event Date 07/09/2018

Event Type  Injury  

Event Description

Consumer stated she/he used two flossers and had a bad reaction both times and suspects the sticks.His/her lips and cheeks swelled up with numbness.

• 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: 7745026
• MDR Text Key: 115893960
• Report Number: 1825660-2018-00379
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• 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: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PKFL MM II 90
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/09/2018
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 08/02/2018
• 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