MAUDE Adverse Event Report: RANIR LLC SONIC PRO; ELECTRIC TOOTHBRUSH REPLACEMENT HEAD

Device Problem Sticking (1597)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/06/2015

Event Type  malfunction  

Event Description

Toothbrush bristles became stuck in consumer's teeth and bristles were released from the brush head.

• Brand Name: SONIC PRO
• Type of Device: ELECTRIC TOOTHBRUSH REPLACEMENT HEAD
• Manufacturer (Section D): RANIR LLC; 4701 east paris se; grand rapids MI 49512 5353
• Manufacturer (Section G): RANIR LLC; 4701 east paris se; grand rapids MI 49512 5353
• Manufacturer Contact: elsa baker ; 4701 east paris ave se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 5059299
• MDR Text Key: 25784188
• Report Number: 1825660-2015-00083
• Device Sequence Number: 1
• Product Code: JEQ
• 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: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2015
• 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
• Date Manufacturer Received: 08/06/2015
• 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