MAUDE Adverse Event Report: RANIR LLC PRESERVE MNTB SOFT; TOOTHBRUSH, MANUAL

Model Number MNTB SOFT CELLO BAG

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2020

Event Type  malfunction  

Event Description

Consumer stated the bristles fell out of their soft preserve toothbrush.No consumer contact information provided, product not returned.

• Brand Name: PRESERVE MNTB SOFT
• Type of Device: TOOTHBRUSH, MANUAL
• 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: 9677269
• MDR Text Key: 184456239
• Report Number: 1825660-2020-00702
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB SOFT CELLO BAG
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/14/2020
• Date Manufacturer Received: 01/14/2020
• 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