MAUDE Adverse Event Report: RANIR LLC EQUATE BR HDS EF II VIP 5PK; TOOTHBRUSH, POWERED

Model Number BR HDS EF II VIP 5PK

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Discomfort (2330)

Event Date 01/28/2019

Event Type  malfunction  

Event Description

Reporter/ patient is claiming that the eq tbp esyflx rf 5ct broke her filling.(b)(6)2019; "purchased them within the past 2 months.Read the back of the package prior to buying and it stated it was compatible with most oral-b power toothbrushes.None of the incompatible brands were the oral-b pro health 3000 smart series that i use.Replaced my oral-b brush head about 1-1/2 weeks ago with the equate (ranir).Used it several days.It seemed more powerful than the oral b but used the lower setting to reduce the brush rotations.I thought it was may be due to being a new brush head that caused the difference.On tuesday 1/22/19, was doing the normal routine of brushing my teeth before going to bed.Brushing the top outside of top right molar and the dental filling on the side top side of my tooth fell out.The filling was thin and was about 1/2 the size of an eraser head on a pencil.Had some discomfort where the filling fell out.The filling had been there for at least 5 years and had no issues prior with that filling.Called the dentist on wednesday 1/23 and was able to have the filling replaced that day.Unfortunately noticed that many of my teeth especially on the right top & bottom of my mouth and a few in the middle have been very sensitive since last wednesday.Even looked at my top teeth with a flashlight and mirror this weekend since the top teeth were hurting so bad and it seemed the surface of at least 1 tooth seemed to be sharper than usual or worn down.They were hurting especially with cold liquids and even hurt several times when going outside in the cold.Was afraid to even bite on the right side of my mouth on the back teeth to prevent the pain.The teeth are still sensitive.May be getting a little better but it comes & goes.Right now the bottom teeth are more sensitive.I try to keep my mind off the sensitivity and that helps.Hoping the sensitivity will go away in time since it has been worrisome about the long term effects.I will gladly return the 3 unused brush heads and 1 used brush head from my husband's toothbrush.Unfortunately i threw my brush head out as soon as this happened not thinking it would need to be evaluated.

• Brand Name: EQUATE BR HDS EF II VIP 5PK
• 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: 8327453
• MDR Text Key: 138699828
• Report Number: 1825660-2019-00506
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BR HDS EF II VIP 5PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/28/2019
• Date Manufacturer Received: 01/28/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1