MAUDE Adverse Event Report: RANIR LLC UP&UP FLSP CNT MNT HT; FLOSS, DENTAL

Model Number FLSP CNT MNT HT 90

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/11/2021

Event Type  malfunction  

Event Description

Guest called into store to say that the floss picks that he purchased the pick part breaks when you fold it out and the floss part is breaking once in use.No contact info provided.

• Brand Name: UP&UP FLSP CNT MNT HT
• 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 hamilton ; 6166988880
• MDR Report Key: 11849992
• MDR Text Key: 258684165
• Report Number: 1825660-2021-00950
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 71031450522
• UDI-Public: 71031450522
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FLSP CNT MNT HT 90
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/20/2021
• Date Manufacturer Received: 04/20/2021
• 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