MAUDE Adverse Event Report: RANIR LLC CVS BR HDS EF II VIP NP 3PK; TOOTHBRUSH, POWERED

Model Number	BR HDS EF II VIP NP 3PK
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer stated "i bought the package of 3 replacement brush heads but it was about 8-10 months ago, and i use it daily.Yesterday while brushing i noticed a foreign object in the back of my mouth.I tried to cough it up to remove it but was unable to do so and started to gag on it.It seemed to go further and further back in my throat and i feared that i would swallow it.Or worse, that it would get into my lungs (i am asthmatic).After about 5 minutes of this coughing and gagging i was able to remove it to find that it was one of the four small black rubbery flaps that are present on the head.I matched it to mine because i found that it had only three of these flaps remaining.I have not sought any medical treatment.".

• Brand Name: CVS BR HDS EF II VIP NP 3PK
• Common Device Name: TOOTHBRUSH, POWERED
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave. se; grand rapids MI 49512 5353
• MDR Report Key: 10425516
• Report Number: 1825660-2020-00793
• Device Sequence Number: 3871093
• Product Code: JEQ
• UDI-Device Identifier: 00050428279717
• UDI-Public: 050428279717
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: BR HDS EF II VIP NP 3PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1