FDA.reportPublic FDA data

MAUDE MDR 5836192

MDR report key
5836192
Report number
MW5063744
Event key
0
Event type
3
Date of event
2016-07-05
Date received
2016-07-27
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
1STERIPODSTERIPODBONFIT AMERICALRJ* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-270

Event Narratives#

D

Patient 1

I PURCHASED A TOOTHBRUSH GUARD CALLED STERIPOD AT (B)(6) BECAUSE I WANTED TO HAVE SOMETHING TO KEEP GERMS FROM GETTING ON THE HEAD OF MY TOOTHBRUSH. THE PACKAGING STATES THAT "ACTIVE VAPORS" KEEP THE TOOTHBRUSH AND BRISTLES CLEAN. A GREEN LIQUID INSIDE THE "ACTIVE VAPORS" POD LEAKED SOME MYSTERIOUS FLUID ALL OVER MY TOOTHBRUSH. WHEN I LOOKED ONLINE TO SEE WHAT IT COULD BE, I FOUND STERIPOD HAD NO MEDICAL DATA OR TESTING WHATSOEVER TO PROVE THAT IT KEPT MY TOOTHBRUSH CLEAN. IN FACT, WITH IT BEING IN AN ENCLOSED SPACE WITH NO AIRFLOW, I SUSPECT THAT IT'S BECOMING A BREEDING GROUND FOR GERMS OR BACTERIA WHEN I USE IT. I HAD SEEN THE SAME PRODUCT FOR SALE AT (B)(6) AND AT (B)(6). I DON'T THINK THEY SHOULD BE ADVERTISING THIS AS A PRODUCT THAT KEEPS TOOTHBRUSHES CLEAN WHEN THEY HAVEN'T WENT TO THE TROUBLE OF DOING ANY TESTING TO SHOW THAT ACTUALLY WORKS AND MAY ACTUALLY MAKE THE TOOTHBRUSH MORE INFESTED WITH GERMS.