N
Patient 1
MEDWATCH 2320643-2017-00002 IS ASSOCIATED WITH ARGUS CASE (B)(4), BREATHE RIGHT NASAL STRIPS EXTRA.
MAUDE MDR 6407989
- MDR report key
- 6407989
- Report number
- 2320643-2017-00002
- Event key
- 0
- Event type
- 3
- Date received
- 2017-03-15
- 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 | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BREATHE RIGHT NASAL STRIPS EXTRA | NASAL STRIPS | WEBTEC A DIVISION OF SCARPA HEALTHCARE | LWF | 491980XXJ16 | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-03-15 | 0 | 1. R |
Event Narratives#
D
Patient 1
CHRONIC SINUS PROBLEMS THAT HAD REQUIRED SURGERY [SINUS DISORDER]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SINUS DISORDER IN A MALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS EXTRA) NASAL STRIP (BATCH NUMBER 491980XXJ16, EXPIRY DATE UNKNOWN) FOR DIFFICULTY BREATHING. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. IN 2008, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS EXTRA. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS EXTRA, THE PATIENT EXPERIENCED SINUS DISORDER (SERIOUS CRITERIA CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED) AND PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE OUTCOME OF THE SINUS DISORDER AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE SINUS DISORDER TO BE RELATED TO BREATHE RIGHT NASAL STRIPS EXTRA. THIS REPORT IS MADE BY (B)(4) WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED BY EMAIL ON 09 MARCH 2017. THE CONSUMER SAID SHE HAD USED BREATH RIGHT PRODUCTS (RIGHT NASAL STRIPS EXTRA) FOR ABOUT NINE YEARS (2008). SHE HAS HAD CHRONIC SINUS PROBLEMS THAT HAD REQUIRED SURGERY THREE TIMES IN THOSE YEARS, MOST RECENTLY LAST WEEK ((B)(6) 2017). SHE STATED THAT SHE FOUND THAT THE PRODUCT WAS THE ONLY SAFE THING TO USE TO BREATH. THE LAST FOUR BOXES SHE HAD ISSUES WITH THE ADHESIVE NOT WORKING AT ONE END OF THE STRIP. THIS PRESENT BOX HAD A FIFTY PERCENT FAILURE OF PRODUCT. THAT WAS NOT AN EXAGGERATION. THE LOT NUMBER WAS 491980XXJ16 ON THE BOX.
N
Patient 1
MFR 2320643-2017-00002 IS ASSOCIATED WITH ARGUS CASE (B)(4), BREATHE RIGHT NASAL STRIPS EXTRA.
D
Patient 1
CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SINUS DISORDER IN A MALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS EXTRA) NASAL STRIP (BATCH NUMBER 491980XXJ16, EXPIRY DATE UNKNOWN) FOR DIFFICULTY BREATHING. THIS CASE WAS ASSOCIATED WITH A PRODUCT COMPLAINT. CONCOMITANT PRODUCTS INCLUDED NO THERAPY. IN 2008, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS EXTRA. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS EXTRA, THE PATIENT EXPERIENCED SINUS DISORDER (SERIOUS CRITERIA CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED) AND PRODUCT COMPLAINT. ON AN UNKNOWN DATE, THE OUTCOME OF THE SINUS DISORDER AND PRODUCT COMPLAINT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE SINUS DISORDER TO BE RELATED TO BREATHE RIGHT NASAL STRIPS EXTRA. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED BY EMAIL ON 09 MARCH 2017. THE CONSUMER SAID SHE HAD USED BREATH RIGHT PRODUCTS (RIGHT NASAL STRIPS EXTRA) FOR ABOUT NINE YEARS (2008). SHE HAS HAD CHRONIC SINUS PROBLEMS THAT HAD REQUIRED SURGERY THREE TIMES IN THOSE YEARS, MOST RECENTLY LAST WEEK ((B)(6) 2017). SHE STATED THAT SHE FOUND THAT THE PRODUCT WAS THE ONLY SAFE THING TO USE TO BREATH. THE LAST FOUR BOXES SHE HAD ISSUES WITH THE ADHESIVE NOT WORKING AT ONE END OF THE STRIP. THIS PRESENT BOX HAD A FIFTY PERCENT FAILURE OF PRODUCT. THAT WAS NOT AN EXAGGERATION. THE LOT NUMBER WAS 491980XXJ16 ON THE BOX. FOLLOW UP INFORMATION WAS RECEIVED ON 16 MARCH 2017. THE REPORTER'S CONTACT DETAILS WERE UPDATED.