FDA.reportPublic FDA data

MAUDE MDR 5236578

MDR report key
5236578
Report number
MW5057959
Event key
0
Event type
3
Date of event
2015-11-11
Date received
2015-11-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THE DOCTOR'S BRUSHPICKSDENTAL HAND INSTRUMENTPRESTIGE BANDELADR081201* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-160

Event Narratives#

D

Patient 1

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.