THE DOCTOR'S BRUSHPICKS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-16 for THE DOCTOR'S BRUSHPICKS manufactured by Prestige Band.

Event Text Entries

[31710220] While using the brushpick interdental toothpicks distributed by (b)(4). I severely lacerated my gums between my teeth. So much so, that it was difficult to brush my teeth in a normal fashion. I could not eat spicy food nor salty food until the gums healed. The brushpicks are extremely sharp and the "knife end of the pick" is sword like. The package claims "that daily use of the doctor's brushpicks will produce a noticeable improvement in your oral health in just two weeks. " i am an avid toothbrusher and i floss at least 3 to 4 times a day. I never miss a dental appointment. I never experienced so much pain and discomfort in my life. The open wounds had the potential to become infected and the risk of periodontal disease rises. The company claims to use an improved "plyalene' for longer lasting bristles. The bristles are sharp and stiff. I sent magnified pictures to the company to show them that i was talking about. The brushpicks are not safe for human use. Dates of use: (b)(6) 2015. Diagnosis or reason for use: dental health. Event abated after use stopped or dose reduced? Yes. Event reappeared after reintroduction? Yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5057959
• MDR Report Key: 5236578
• Date Received: 2015-11-16
• Date of Report: 2015-11-16
• Date of Event: 2015-11-11
• Date Added to Maude: 2015-11-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: THE DOCTOR'S BRUSHPICKS
• Generic Name: DENTAL HAND INSTRUMENT
• Product Code: ELA
• Date Received: 2015-11-16
• Lot Number: DR081201
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PRESTIGE BAND

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-11-16