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

Model Number	FLSP CNT MNT HT 90
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer posted review on amazon that "the plastic toothpick end always breaks and the floss string breaks as well.Unusable" no contact info provided.

• Brand Name: SOLIMO FLSP CNT MNT HT
• Common Device Name: FLOSS, DENTAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 10446235
• Report Number: 1825660-2020-00798
• Device Sequence Number: 3000004
• Product Code: JES
• UDI-Device Identifier: 00842379146923
• UDI-Public: 842379146923
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: FLSP CNT MNT HT 90
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2020
• Initial Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1