BREATHE RIGHT NASAL STRIPS CLEAR

Report

Report Number: 2320643-2017-00010
Event Type: Injury
Date Received: November 9, 2017
Date of Event: October 23, 2017
Report Date: November 2, 2017
Manufacturer: WEBTEC A DIVISION OF SCARPA HEALTHCARE
Product Code: LWF
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

IS ASSOCIATED WITH ARGUS CASE (B)(4), BREATHE RIGHT NASAL STRIPS CLEAR. QA RESULTS: EACH BATCH OF STRIPS IS TESTED FOR ALL REQUIRED QUALITY CHARACTERISTICS DURING MANUFACTURING AND PACKAGING. ONLY APPROVED MATERIALS ARE USED IN ANY LOT OF BREATHE RIGHT NASAL STRIPS. ANY LOT THAT EXHIBITED DEFECTS OR IMPROPER PERFORMANCE CHARACTERISTICS WOULD FAIL SUCH TESTING AND WOULD NOT BE RELEASED TO THE MARKET. SAMPLES HAVE BEEN RETURNED FROM LOT 50946HTC17. THE DEVICE HISTORY RECORD FROM THIS STRIP BATCH CONFIRMS THAT ONLY RELEASED, STANDARD MATERIALS WERE USED IN THE BATCH. RETAIN SAMPLES FROM THE LOT ARE NORMAL IN APPEARANCE AND THE SAMPLES RETURNED SHOW NO SIGNS OF UNUSUALLY STRONG ADHESION. THERE IS NO EVIDENCE TO SUBSTANTIATE THIS COMPLAINT.

Additional Manufacturer Narrative · 1

2320643-2017-00010 IS ASSOCIATED WITH ARGUS CASE (B)(4), BREATHE RIGHT NASAL STRIPS CLEAR.

Description of Event or Problem · 1

CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF APPLICATION SITE IRRITATION IN A (B)(6) FEMALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS CLEAR) NASAL STRIP (BATCH NUMBER 50946HTC17, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED ALLERGY TO PLANTS (ALLERGIC TO POISON IVIES). CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON (B)(6) 2017, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS CLEAR. ON (B)(6) 2017, 1 DAYS AFTER STARTING BREATHE RIGHT NASAL STRIPS CLEAR, THE PATIENT EXPERIENCED APPLICATION SITE IRRITATION (SERIOUS CRITERIA OTHER: PER REPORTER) AND APPLICATION SITE REDNESS. THE PATIENT WAS TREATED WITH ALOE BARBADENSIS (ALOE VERA). ON AN UNKNOWN DATE, THE OUTCOME OF THE APPLICATION SITE IRRITATION AND APPLICATION SITE REDNESS WERE UNKNOWN. THE REPORTER CONSIDERED THE APPLICATION SITE IRRITATION TO BE RELATED TO BREATHE RIGHT NASAL STRIPS CLEAR. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE APPLICATION SITE REDNESS TO BE RELATED TO BREATHE RIGHT NASAL STRIPS CLEAR. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2017. CONSUMER REPORTED THAT "MY RECENT BOX OF BREATHE RIGHT CLEAR HAS GIVEN ME A SERIOUS SKIN IRRITATION ACROSS THE BRIDGE OF MY NOSE WHEREVER THE STRIP TOUCHED. THIS WAS WORSE THAN ANY IRRITATION FROM WHEN I USED THE STRONGER STRIPS IN THE PAST. I AM NOT ALLERGIC TO ADHESIVES OR ANYTHING ELSE THAT I KNOW OF EXCEPT POISON IVIES". FOLLOW UP INFORMATION WAS RECEIVED ON 3 NOVEMBER 2017. CONSUMER REPORTED THAT SHE STARTED USING THE PRODUCT ON (B)(6) 2017. SHE STATED THAT ON (B)(6) 2017 HER NOSE BECAME REALLY RED AND WAS RAW IN SOME AREAS. CONSUMER STATED SHE USED ALOE VERA TO HELP HEAL HER NOSE. SHE STOPPED USING THE NASAL STRIPS ON (B)(6) 2017. INITIAL AND FOLLOW UP INFORMATION WAS INCLUDED IN ABOVE NARRATIVE. THE ADVERSE EVENT REVISION WAS RECEIVED ON (B)(6) 2017. THE EVENT OF PRODUCT COMPLAINT WAS ADDED TO THE CASE. THE EVENT OUTCOME FOR PRODUCT COMPLAINT WAS UNKNOWN. THE CAUSALITY FOR PRODUCT COMPLAINT WAS NOT APPLICABLE. FOLLOW UP INFORMATION WAS RECEIVED ON 28 NOVEMBER 2017. PRODUCT SAMPLE BREATHE RIGHT NASAL STRIPS, 30CT, RECEIVED. THE LOT NUMBER REPORTED WERE 5094T1108219 AND STRIP LOT NUMBER AS 50946HTC17. THE LOT NUMBER OF 5094T1108219 WAS ADDED TO THE CASE. FOLLOW-UP INFORMATION WAS RECEIVED ON 08 DECEMBER 2017 FROM THE QUALITY ASSURANCE (QA) DEPARTMENT REGARDING COMPLAINT NUMBER (B)(4) AND LOT NUMBER 50946HTC17. QUALITY INVESTIGATION REPORT INCLUDED THAT SAMPLES HAD BEEN RETURNED FROM LOT NUMBER 50946HTC17. THE DEVICE HISTORY RECORD FROM THIS STRIP BATCH CONFIRMED THAT ONLY RELEASED, STANDARD MATERIALS WERE USED IN THE BATCH. RETAIN SAMPLES FROM THE LOT WERE NORMAL IN APPEARANCE AND THE SAMPLES RETURNED SHOW NO SIGNS OF UNUSUALLY STRONG ADHESION. THERE WAS NO EVIDENCE TO SUBSTANTIATE THIS COMPLAINT.

Description of Event or Problem · 1

CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF APPLICATION SITE IRRITATION IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS CLEAR) NASAL STRIP (BATCH NUMBER 50946HTC17, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED ALLERGY TO PLANTS (ALLERGIC TO POISON IVIES). CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON (B)(6) 2017, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS CLEAR. ON (B)(6) 2017, 1 DAYS AFTER STARTING BREATHE RIGHT NASAL STRIPS CLEAR, THE PATIENT EXPERIENCED APPLICATION SITE IRRITATION (SERIOUS CRITERIA OTHER: PER REPORTER) AND APPLICATION SITE REDNESS. THE PATIENT WAS TREATED WITH ALOE BARBADENSIS (ALOE VERA). ON AN UNKNOWN DATE, THE OUTCOME OF THE APPLICATION SITE IRRITATION AND APPLICATION SITE REDNESS WERE UNKNOWN. THE REPORTER CONSIDERED THE APPLICATION SITE IRRITATION TO BE RELATED TO BREATHE RIGHT NASAL STRIPS CLEAR. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE APPLICATION SITE REDNESS TO BE RELATED TO BREATHE RIGHT NASAL STRIPS CLEAR. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED VIA EMAIL ON 2 NOVEMBER 2017. CONSUMER REPORTED THAT "MY RECENT BOX OF BREATHE RIGHT CLEAR HAS GIVEN ME A SERIOUS SKIN IRRITATION ACROSS THE BRIDGE OF MY NOSE WHEREVER THE STRIP TOUCHED. THIS WAS WORSE THAN ANY IRRITATION FROM WHEN I USED THE STRONGER STRIPS IN THE PAST. I AM NOT ALLERGIC TO ADHESIVES OR ANYTHING ELSE THAT I KNOW OF EXCEPT POISON IVIES." FOLLOW UP INFORMATION WAS RECEIVED ON 3 NOVEMBER 2017. CONSUMER REPORTED THAT SHE STARTED USING THE PRODUCT ON (B)(6) 2017. SHE STATED THAT ON (B)(6) 2017 HER NOSE BECAME REALLY RED AND WAS RAW IN SOME AREAS. CONSUMER STATED SHE USED ALOE VERA TO HELP HEAL HER NOSE. SHE STOPPED USING THE NASAL STRIPS ON (B)(6) 2017. INITIAL AND FOLLOW UP INFORMATION WAS INCLUDED IN ABOVE NARRATIVE. THE ADVERSE EVENT REVISION WAS RECEIVED ON 09 NOVEMBER 2017. THE EVENT OF PRODUCT COMPLAINT WAS ADDED TO THE CASE. THE EVENT OUTCOME FOR PRODUCT COMPLAINT WAS UNKNOWN. THE CAUSALITY FOR PRODUCT COMPLAINT WAS NOT APPLICABLE.

Description of Event or Problem · 1

BREATHERITE CLEAR HAS GIVEN ME A SERIOUS SKIN IRRITATION ACROSS THE BRIDGE OF MY NOSE WHEREVER THE STRIP TOUCHED/ ON (B)(6) 2017 THAT HER NOSE WAS RAW IN SOME AREAS [APPLICATION SITE IRRITATION]. ON (B)(6) 2017 THAT HER NOSE BECAME REALLY RED [APPLICATION SITE REDNESS]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF APPLICATION SITE IRRITATION IN A (B)(6) -YEAR-OLD FEMALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS (BREATHE RIGHT NASAL STRIPS CLEAR) NASAL STRIP (BATCH NUMBER 50946HTC17, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED ALLERGY TO PLANTS (ALLERGIC TO POISON IVIES). CONCOMITANT PRODUCTS INCLUDED NO THERAPY. ON (B)(6) 2017, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS CLEAR. ON (B)(6) 2017, 1 DAYS AFTER STARTING BREATHE RIGHT NASAL STRIPS CLEAR, THE PATIENT EXPERIENCED APPLICATION SITE IRRITATION (SERIOUS CRITERIA OTHER: PER REPORTER) AND APPLICATION SITE REDNESS. THE PATIENT WAS TREATED WITH ALOE BARBADENSIS (ALOE VERA). ON AN UNKNOWN DATE, THE OUTCOME OF THE APPLICATION SITE IRRITATION AND APPLICATION SITE REDNESS WERE UNKNOWN. THE REPORTER CONSIDERED THE APPLICATION SITE IRRITATION TO BE RELATED TO BREATHE RIGHT NASAL STRIPS CLEAR. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE APPLICATION SITE REDNESS TO BE RELATED TO BREATHE RIGHT NASAL STRIPS CLEAR. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED VIA EMAIL ON (B)(6) 2017. CONSUMER REPORTED THAT "MY RECENT BOX OF BREATHE RIGHT CLEAR HAS GIVEN ME A SERIOUS SKIN IRRITATION ACROSS THE BRIDGE OF MY NOSE WHEREVER THE STRIP TOUCHED. THIS WAS WORSE THAN ANY IRRITATION FROM WHEN I USED THE STRONGER STRIPS IN THE PAST. I AM NOT ALLERGIC TO ADHESIVES OR ANYTHING ELSE THAT I KNOW OF EXCEPT POISON IVIES". FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2017. CONSUMER REPORTED THAT SHE STARTED USING THE PRODUCT ON (B)(6) 2017. SHE STATED THAT ON (B)(6) 2017 HER NOSE BECAME REALLY RED AND WAS RAW IN SOME AREAS. CONSUMER STATED SHE USED ALOE VERA TO HELP HEAL HER NOSE. SHE STOPPED USING THE NASAL STRIPS ON (B)(6) 2017. INITIAL AND FOLLOW UP INFORMATION WAS INCLUDED IN ABOVE NARRATIVE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
794675	BREATHE RIGHT NASAL STRIPS CLEAR	NASAL STRIPS	LWF	WEBTEC A DIVISION OF SCARPA HEALTHCARE		50946HTC17

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Other