MAUDE Adverse Event Report: RANIR LLC MULTIANGLE TOOTHBRUSH; MANUAL TOOTHBRUSH

Device Problem Component Falling (1105)

Patient Problem No Information (3190)

Event Date 01/25/2016

Event Type  malfunction  

Manufacturer Narrative

Device not returned, no malfxn pattern.

Event Description

Bristles are falling out of toothbrush.

• Brand Name: MULTIANGLE TOOTHBRUSH
• Type of Device: MANUAL TOOTHBRUSH
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids 49512 0000
• Manufacturer Contact: elsa baker ; 4701 east paris se; grand rapids 49512-0000 ; 6166988880
• MDR Report Key: 5445455
• MDR Text Key: 39001219
• Report Number: 1825660-2016-00009
• 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: company representative,consum
• Reporter Occupation: Device Unattended
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2016
• Initial Date FDA Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: No
• 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