MAUDE Adverse Event Report: QUIP QUIP BRUSH HEAD REPLACEMENT; TOOTHBRUSH POWERED

Device Problem Microbial Contamination of Device (2303)

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

Event Date 05/08/2020

Event Type  malfunction  

Event Description

High risk to patient health; i use quip toothbrushes and subscribe to their monthly refill service that includes a brush head and new battery.Until this last refill, the items were sent in a sealed package to ensure it is not exposed to outside pathogens or contamination in mailing, processing etc.They have changed to paper packaging that has caused severe issues in regards to patient health.My dentist was appalled as are many dentists.My entire clinic no longer recommends quip because of this.I open the package which again is now just a paper insert thrown together without any concern for patient health and safety.The brush head is placed without protection into a paper tube that has the potential to build moisture and mildew, not to mention it is exposed to outside air, contamination from water, gasoline, and other fluids commonly come across during shipping.The envelope sent in is no longer sealed from outside elements allowing for bugs, microscopic organisms, and other potentially dangerous and deadly microbial infestation of the product.My package for instance was soaked when it arrived because of the weather conditions that day.The water seeped through into the package, wet the paper insert, soaked into the brush head paper tube, caused the brush head to smell musty and moldy, caused the inside of the tube to develop black spots of mold and mildew around the opposite end top, contained specs of dust or dirt inside the tube.The paper insert caused cuts to my hands because it was insufficient to bear the weight of the items it was attempting to hold.This is completely unacceptable and the company deserves to be heavily fined for this.They are an oral health company.There is absolutely zero tolerance or reasons for any company to do this.I don't care what the excuses are.Fine them.Fda safety report id# (b)(4).

• Brand Name: QUIP BRUSH HEAD REPLACEMENT
• Type of Device: TOOTHBRUSH POWERED
• Manufacturer (Section D): QUIP
• MDR Report Key: 10051343
• MDR Text Key: 190959993
• Report Number: MW5094462
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 82