FDA Adverse Event Injury Summary report: N

SUPER POLIGRIP EXTRA CARE

MDR report key: 2982649 · Received February 21, 2013

Report

Report Number
MW5029132
Event Type
Injury
Date Received
February 21, 2013
Date of Event
December 15, 2012
Report Date
February 21, 2013
Product Code
KOT
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

ABOUT (B)(6) 2012 STARTING USING "SUPER POLI-GRIP EXTRA CARE DENTURE ADHESIVE CREAM ZINC-FREE" ON MY UPPER DENTURE. BY (B)(6) I STARTED EXPERIENCING CONTINUOUS TINNITUS ALTHOUGH I HAVE NO KNOWN RISK FACTORS. WITH THE PREVIOUS ZINC-CONTAINING FORMULA TINNITUS HD BEEN REPORTED IN THE LITERATURE. I SPOKE WITH MY DENTIST. HE ADVISED ME TO TRY NOT USING THE DENTAL ADHESIVE AND SEE IF THE PROBLEM GOES AWAY. AFTER THREE DAYS OFF THE ADHESIVE THE TINNITUS ENDED. I WENT A WEEK WITHOUT TINNITUS AND REAPPLIED ONLY ONE DAB OF ADHESIVE FOR SKIING AND LEFT IT ON FOR 14 HRS. THE NEXT MORNING I WAS EXPERIENCING TINNITUS AGAIN. IT TOOK TWO FULL DAYS FOR THE TINNITUS TO CLEAR. I AM NOW TOTALLY FREE OF THE TINNITUS. I AM FEARFUL OF USING THE ADHESIVE CREAM AGAINST MY UPPER PALATE FOR ANYTHING MORE THAN WHEN I AM LECTURING OR SKIING. (B)(6). IT IS VERY EVIDENT TO ME THAT WHEN I HEAR A BUZZING ELECTRONIC LIKE SOUND LIKE THE WHITE NOISE OF AN OLD FLUORESCENT BALLAST WHEN THERE ARE NO FLUORESCENTS ON. THE SOUND IS NOT DIRECTIONAL AND WEARING SOUND PROTECTORS DOES NOT INFLUENCE WHAT I HEAR. IT IS QUITE CLEAR TO ME WHEN I AM EXPERIENCING TINNITUS. MY HEARING IS EXCELLENT BOTH WITH AND WITHOUT TINNITUS. DOSE OR AMOUNT: ONE TO THREE DABS. DATES OF USE: (B)(6) 2012 - (B)(6) 2013. DIAGNOSIS OR REASON FOR USE: PROBLEM OF RELATIVELY LOOSE UPPER DENTURE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
76029 SUPER POLIGRIP EXTRA CARE DENTURE ADHESIVE CREAM KOT 98138XF R12271

Patients

Seq Age Sex Outcome Treatment
1 80 YR Other