MAUDE Adverse Event Report: RANIR LLC MEIJER; TOOTHBRUSH, POWERED

Model Number BR HDS SMSNC II 5PK

Device Problems Break (1069); Vibration (1674)

Patient Problem Tooth Fracture (2428)

Event Date 12/13/2018

Event Type  Injury  

Event Description

She stated that while using the brush heads she noticed they vibrated much more aggressively.She noticed that the brush seemed to be damaging her gums.She tried using one of the other brush heads from the package, hoping it would resolve the issue but had the same problem.She then stated that on one occasion she chipped one of her front teeth while using the brush head, the plastic part of the brush head hit her tooth.She did not recall the date or time of the incident, but estimated that it was about two months ago.

• Brand Name: MEIJER
• Type of Device: TOOTHBRUSH, POWERED
• 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: rebekah stenske ; 4701 east paris ave. se; grand rapids, MI 49512-5353 ; 6166988880
• MDR Report Key: 8224047
• MDR Text Key: 132334935
• Report Number: 1825660-2019-00469
• 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: Other
• Type of Report: Initial
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BR HDS SMSNC II 5PK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Distributor Facility Aware Date: 12/13/2018
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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