MAUDE Adverse Event Report: INTRADENTAL BRUSH CLEANERS

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 05/06/2019

Event Type  Injury  

Event Description

Reporter stated that he started using the intradermal brush cleaner about a week ago and observed that the bristles on the brush where falling off and he as not sure of the location of the fallen off bristles.He mentioned that this was not the case with other competitor's brushes.

• Brand Name: INTRADENTAL BRUSH CLEANERS
• Type of Device: INTRADENTAL BRUSH CLEANERS
• MDR Report Key: 8608499
• MDR Text Key: 145211040
• Report Number: MW5086622
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR