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

Model Number FLSP CNT MNT HT 90

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2020

Event Type  malfunction  

Event Description

Consumer stated when you "flip thing over the flosser to use the tooth pick it breaks after a few uses and that could break apart cause a person to swallow." product was not returned for review.

• Brand Name: HEB 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 stenske ; 6166988880
• MDR Report Key: 9655575
• MDR Text Key: 184454924
• Report Number: 1825660-2020-00700
• Device Sequence Number: 1
• Product Code: JES
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• 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: 01/13/2020
• Date Manufacturer Received: 01/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1