MAUDE Adverse Event Report: RANIR LLC CVS MNTB TRDRP ME 3PK; TOOTHBRUSH, MANUAL

Model Number MNTB TRDRP ME 3PK

Device Problem Device Fell (4014)

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

Event Date 10/22/2019

Event Type  malfunction  

Event Description

Consumer stated she purchased two packs of a 3 pack of toothbrushes.She stated the bristles on every brush would fall off after a couple of uses; she used 5 brushes over the course of 3-4 months.Consumer was contacted and she no longer had the brushes.

• Brand Name: CVS MNTB TRDRP ME 3PK
• 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: 9336871
• MDR Text Key: 175842229
• Report Number: 1825660-2019-00652
• Device Sequence Number: 1
• Product Code: EFW
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB TRDRP ME 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/23/2019
• Date Manufacturer Received: 10/23/2019
• 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