MAUDE Adverse Event Report: RANIR LLC EASY FLEX RBH; REPLACEMENT POWER TOOTHBRUSH HEADS

Device Problem Component Falling (1105)

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

Event Date 05/08/2015

Event Type  No Answer Provided  

Event Description

The bristles are falling out while he is brushing.

• Brand Name: EASY FLEX RBH
• Type of Device: REPLACEMENT POWER TOOTHBRUSH HEADS
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512 535
• MDR Report Key: 4823285
• MDR Text Key: 5909518
• Report Number: 1825660-2015-00018
• 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: Device Unattended
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/07/2015

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?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 06/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1