MAUDE Adverse Event Report: RANIR LLC TARGET BRANDPST COLGATE REG CD; TOOTHBRUSH, MANUAL

Model Number BRANDPST COLGATE REG CD

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/31/2021

Event Type  malfunction  

Event Description

Please be aware that my toothbrush disintegrated in the middle of first use.All the bristles came off.Consumer replied back with he threw the tb out.

Manufacturer Narrative

No samples provided.Unable to review travel toothbrush for bristles falling out.Can not confirm complaint.Complaint trending for travel toothbrush was reviewed for the 13 months leading up to (b)(6) 2021 and there is not an increasing trend for travel toothbrush bristles falling out failure mode.This is the only complaint for bristles falling out.Continue to monitor via complaint reviews and complaint review monthly meetings.

• Brand Name: TARGET BRANDPST COLGATE REG CD
• 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: amber moffett ; 6166988880
• MDR Report Key: 12894820
• MDR Text Key: 282839250
• Report Number: 1825660-2021-01026
• Device Sequence Number: 1
• Product Code: EFW
• UDI-Device Identifier: 00071031511407
• UDI-Public: 071031511407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BRANDPST COLGATE REG CD
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/01/2021
• Date Manufacturer Received: 11/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male