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

Model Number FLSP CNT MNT HT 90

Device Problems Product Quality Problem (1506); Use of Device Problem (1670)

Patient Problem Failure of Implant (1924)

Event Date 04/24/2021

Event Type  malfunction  

Event Description

Review posted on (b)(6): they are horrible little picks.Actually pulled my crown out.No contact information.

• Brand Name: SOLIMO 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: 11866925
• MDR Text Key: 255143718
• Report Number: 1825660-2021-00960
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 00842379146930
• UDI-Public: 842379146930
• 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: 05/21/2021

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: FLSP CNT MNT HT 90
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/24/2021
• Initial Date Manufacturer Received: 04/24/2021
• Initial Date FDA Received: 05/21/2021
• 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