FDA.reportPublic FDA data

MAUDE MDR 6387520

MDR report key
6387520
Report number
2320643-2017-00001
Event key
0
Event type
3
Date received
2017-03-08
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 STRIPSNASAL STRIPSWEBTEC A DIVISION OF SCARPA HEALTHCARELWFR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-0801. O

Event Narratives#

N

Patient 1

REPORT # 2320643-2017-00001 IS ASSOCIATED WITH (B)(4), BREATHE RIGHT NASAL STRIPS.

D

Patient 1

NOSE IS RAW/ HAVE BEEN TREATING IT FOR 5 DAYS. STILL RAW [NASAL PASSAGE IRRITATION] LAST ONE I TOOK OFF BROUGHT SKIN N ALL OFF. IT REALLY LOOKS SERIOUS [APPLICATION SITE DESQUAMATION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF NASAL PASSAGE IRRITATION IN A FEMALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS NASAL STRIP (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PATIENT EXPERIENCED NASAL PASSAGE IRRITATION (SERIOUS CRITERIA OTHER: AS PER REPORTER) AND APPLICATION SITE DESQUAMATION (SERIOUS CRITERIA OTHER: AS PER REPORTER). THE ACTION TAKEN WITH BREATHE RIGHT NASAL STRIPS WAS UNKNOWN (DECHALLENGE WAS NEGATIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE NASAL PASSAGE IRRITATION WAS NOT RECOVERED/NOT RESOLVED AND THE OUTCOME OF THE APPLICATION SITE DESQUAMATION WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE NASAL PASSAGE IRRITATION AND APPLICATION SITE DESQUAMATION TO BE RELATED TO BREATHE RIGHT NASAL STRIPS. ADDITIONAL DETAILS: ADVERSE EVENT INFORMATION WAS RECEIVED ON 23 FEBRUARY 2017. CONSUMER REPORTED BREATHE RIGHT VARIANT NOT SPECIFIED. THE CONSUMER REPORTED THAT "I LIKE THEM TO BUT MY NOSE IS RAW. THE LAST ONE I TOOK OFF BROUGHT SKIN AND ALL OFF. IT REALLY LOOKS SERIOUS. I HAVE BEEN TREATING IT FOR 5 DAYS. STILL RAW". LOT AND EXPIRATION DATE WAS NOT PROVIDED.

D

Patient 1

NOSE IS RAW/ HAVE BEEN TREATING IT FOR 5 DAYS. STILL RAW [APPLICATION SITE IRRITATION] LAST ONE I TOOK OFF BROUGHT SKIN N ALL OFF. IT REALLY LOOKS SERIOUS [APPLICATION SITE DESQUAMATION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF NASAL PASSAGE IRRITATION IN A FEMALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS NASAL STRIP (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON AN UNKNOWN DATE, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PATIENT EXPERIENCED NASAL PASSAGE IRRITATION (SERIOUS CRITERIA OTHER: AS PER REPORTER) AND APPLICATION SITE DESQUAMATION (SERIOUS CRITERIA OTHER: AS PER REPORTER). THE ACTION TAKEN WITH BREATHE RIGHT NASAL STRIPS WAS UNKNOWN (DECHALLENGE WAS NEGATIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE NASAL PASSAGE IRRITATION WAS NOT RECOVERED/NOT RESOLVED AND THE OUTCOME OF THE APPLICATION SITE DESQUAMATION WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE NASAL PASSAGE IRRITATION AND APPLICATION SITE DESQUAMATION TO BE RELATED TO BREATHE RIGHT NASAL STRIPS. 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 23 FEBRUARY 2017. CONSUMER REPORTED BREATHE RIGHT VARIANT NOT SPECIFIED. THE CONSUMER REPORTED THAT "I LIKE THEM TO BUT MY NOSE IS RAW. THE LAST ONE I TOOK OFF BROUGHT SKIN AND ALL OFF. IT REALLY LOOKS SERIOUS. I HAVE BEEN TREATING IT FOR 5 DAYS. STILL RAW". LOT AND EXPIRATION DATE WAS NOT PROVIDED. THIS REPORT IS BEING RESUBMITTED TO CAPTURE CORRECTIONS FOR INITIAL VERSION DATED ON 23 FEBRUARY 2017. THE EVENT OF NASAL PASSAGE IRRITATION WAS CHANGED TO APPLICATION SITE IRRITATION. ON AN UNKNOWN DATE, THE OUTCOME OF THE APPLICATION SITE IRRITATION WAS NOT RECOVERED/NOT RESOLVED. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE APPLICATION SITE IRRITATION TO BE RELATED TO BREATHE RIGHT NASAL STRIPS. NO MORE CORRECTIONS WERE MADE.