FDA.reportPublic FDA data

MAUDE MDR 6905307

MDR report key
6905307
Report number
2320643-2017-00009
Event key
0
Event type
3
Date received
2017-09-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Address
PO BOX 13398 RESEARCH TRIANGLE PARK NC 27709 US
Phone
888-888-8888
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BREATHE RIGHT NASAL STRIPS EXTRA CLEARNASAL STRIPSWEBTEC A DIVISION OF SCARPA HEALTHCARELWFUNKR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-2901. O

Event Narratives#

N

Patient 1

THIS REPORT IS ASSOCIATED WITH (B)(4), BREATHE RIGHT NASAL STRIPS EXTRA CLEAR.

D

Patient 1

I TOLERATE THE CLEAR WELL. I AM ADDICTED TO THEM (BREATHE RIGHT NASAL STRIPS EXTRA CLEAR) [ADDICTION] CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ADDICTION IN A MALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS EXTRA CLEAR) NASAL STRIP (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DIFFICULTY BREATHING. CO-SUSPECT PRODUCTS INCLUDED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS TAN) NASAL STRIP (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DIFFICULTY BREATHING. CONCURRENT MEDICAL CONDITIONS INCLUDED HYPERESTHESIA. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS EXTRA CLEAR AND BREATHE RIGHT NASAL STRIPS TAN. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS EXTRA CLEAR AND BREATHE RIGHT NASAL STRIPS TAN, THE PATIENT EXPERIENCED ADDICTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), APPLICATION SITE REACTION, APPLICATION SITE REDNESS AND APPLICATION SITE IRRITATION. BREATHE RIGHT NASAL STRIPS EXTRA CLEAR WAS DISCONTINUED (DECHALLENGE WAS NEGATIVE). BREATHE RIGHT NASAL STRIPS TAN WAS DISCONTINUED (DECHALLENGE WAS NEGATIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE ADDICTION, APPLICATION SITE REACTION, APPLICATION SITE REDNESS AND APPLICATION SITE IRRITATION WERE NOT RECOVERED/NOT RESOLVED. THE REPORTER CONSIDERED THE ADDICTION TO BE RELATED TO BREATHE RIGHT NASAL STRIPS EXTRA CLEAR. THE REPORTER CONSIDERED THE APPLICATION SITE REACTION, APPLICATION SITE REDNESS AND APPLICATION SITE IRRITATION TO BE RELATED TO BREATHE RIGHT NASAL STRIPS TAN. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON 27 SEPTEMBER 2017. CONSUMER REPORTED THAT "BREATHE RIGHT, CLEAR, L, 30 CT. I USE THEM EVERY NIGHT. THREE STORES DO NOT HAVE IT ANYMORE. THEY DO NOT HAVE SHELF SPACE FOR IT ANY LONGER. THE TAN ONES IRRITATES MY SENSITIVE NOSE. IT MAKES MORE INDENTATIONS AND I WAKE UP TO A RED NOSE. I TOLERATE THE CLEAR WELL. I AM ADDICTED TO THEM".