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

Model Number FLSP CNT MNT HT 90

Device Problems Material Too Rigid or Stiff (1544); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/25/2020

Event Type  malfunction  

Event Description

Consumer posted on amazon: when i try to bend the pick part back for use it snaps off.With plackers they do not snap off.The plastic is just a bit too rigid.For this reason i wouldn't buy again (in 2 years when i use all of these, lol) but.If i knew they fixed the issue i definitely would buy gain.".

• 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: 11231163
• MDR Text Key: 229840979
• Report Number: 1825660-2021-00899
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 4237914693
• UDI-Public: 4237914693
• 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: 01/26/2021

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: FLSP CNT MNT HT 90
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/08/2021
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/26/2021
• 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