BREATHE RIGHT EXTRA CLEAR
Report
- Report Number
- 3010200299-2021-00002
- Event Type
- Injury
- Date Received
- December 8, 2021
- Date of Event
- November 17, 2021
- Report Date
- January 21, 2022
- Manufacturer
- FOUNDATION CONSUMER BRANDS, LLC
- Product Code
- LWF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURER NARRATIVE: CONSUMER REPORTED USING A BREATHE RIGHT EXTRA STRENGTH CLEAR NASAL STRIP ONE TIME AND WORE IT OVERNIGHT FOR AN UNSPECIFIED INDICATION. THE CONSUMER PROVIDED THE LOT CODE FOR THE PRODUCT, CODE 1207617. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE LOT CODE NUMBER PROVIDED. THE CONSUMER WAS CONTACTED REGARDING RETURNING ANY LEFTOVER PRODUCT FOR INVESTIGATION AND ARE AWAITING THE CONSUMER'S RESPONSE. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE REPORT INVESTIGATION WAS RECEIVED ON 31-DEC-2021. THE VERBATIM IS AS FOLLOWS: EACH BATCH OF STRIPS ARE TESTED FOR ALL REQUIRED QUALITY CHARACTERISTICS DURING MANUFACTURING. ONLY APPROVED MATERIALS ARE USED IN ANY LOT OF BREATHE RIGHT NASAL STRIPS. ANY LOT WHICH EXHIBITS DEFECTS OR IMPROPER PERFORMANCE WOULD FAIL SUCH TESTING AND WOULD NOT BE RELEASED TO THE MARKET. LABORATORY TEST REPORTS FOR LOT IN QUESTION CONFIRMS THE RETAIN SAMPLES HAD NORMAL ADHESION AND SPRING FORCE WITHIN SPECIFICATION LIMITS, AT THE TIME THE LOT WAS RELEASED FOR SALE. NO ISSUES WERE OBSERVED DURING THE MANUFACTURING OF THE LOT 1207617 MATERIALS THAT WOULD AFFECT THE ADHESIVE. NO MATERIALS ASSOCIATED WITH LOT 1207617 WERE DEEMED TO BE NON-CONFORMING FOR ADHESIVE. ALL BREATHE RIGHT STRIP CARTONS CONTAIN AN IFU (INSTRUCTIONS FOR USE) THAT STATES: "CAUTION . .. DO NOT USE OVER SORES ... OR IRRITATED SKIN ... IF RASH OR IRRITATION OCCURS, DISCONTINUE USE." WITHOUT SAMPLES FROM THE COMPLAINT, WE CANNOT EVALUATE THE STRIPS IN QUESTION FOR PERFORMANCE. THIS COMPLAINT HAS NOT PROVIDED ENOUGH EVIDENCE TO SUBSTANTIATE THE COMPLAINT THAT STRIP MANUFACTURING OR ADHESIVE MATERIALS ARE THE CAUSE. COMPANY COMMENT: AFTER USING THE BREATHE RIGHT EXTRA STRENGTH CLEAR NASAL STRIP OVERNIGHT AN OLDER, FEMALE CONSUMER EXPERIENCED SIGNS AND SYMPTOMS AROUND THE APPLICATION SITE AND HER EYES THAT WERE SUGGESTIVE OF A LOCAL HYPERSENSITIVITY REACTION. SHE RECEIVED APPROPRIATE TREATMENT IN AN URGENT CARE CENTER WHICH HELPED TO RESOLVE THE SYMPTOMS AND REACTION OVER THE COURSE OF SEVERAL DAYS. THE COMPLAINT SAMPLE WAS REQUESTED FROM THE CONSUMER, AND AN INVESTIGATION WAS OPENED (B)(6) 2021 BASED ON THE LOT NUMBER PROVIDED BY THE CONSUMER. THE TESTING OF RETAIN SAMPLES AND REVIEW OF PRODUCTION BATCH SPECIFICATIONS HAVE NOT FOUND ANY DEFECTS, BUT A CAUSAL RELATIONSHIP BETWEEN OVERNIGHT USE OF A BREATHE RIGHT STRIP AND THE OBSERVED ADVERSE REACTION IS PROBABLE. IT CANNOT BE EXCLUDED THAT THE CONSUMER EXPERIENCED A HYPERSENSITIVITY REACTION TO ONE OF THE MATERIAL COMPONENTS OF THE PRODUCT, MOST LIKELY THE ADHESIVE USED TO HOLD THE NASAL STRIP IN PLACE. THE INVESTIGATION WAS CLOSED ON DECEMBER 31, 2021 IN THE ABSENCE OF RECEIVING THE ACTUAL PRODUCT FOR INVESTIGATION.
CONSUMER REPORTED USING A BREATHE RIGHT EXTRA STRENGTH CLEAR NASAL STRIP ONE TIME AND WORE IT OVERNIGHT FOR AN UNSPECIFIED INDICATION. THE CONSUMER PROVIDED THE LOT CODE FOR THE PRODUCT, CODE 1207617. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE LOT CODE NUMBER PROVIDED. THE CONSUMER WAS CONTACTED REGARDING RETURNING ANY LEFTOVER PRODUCT FOR INVESTIGATION AND ARE AWAITING THE CONSUMER'S RESPONSE.
ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES VIA TELEPHONE REGARDING A 61-YEAR-OLD FEMALE WHO USED A BREATHE RIGHT EXTRA CLEAR NASAL STRIP. MEDICAL HISTORY INCLUDED A PART OF HER KIDNEY WAS REMOVED (NOT FURTHER SPECIFIED). ALLERGIES INCLUDED ANTIBIOTICS AND SEASONAL ALLERGIES. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON (B)(6) 2021, THE CONSUMER APPLIED A BREATHE RIGHT EXTRA CLEAR (LOT NUMBER: 1207617; EXPIRATION DATE NOT PROVIDED) AS DIRECTED ON THE PACKAGE ONE TIME AND WORE IT OVERNIGHT FOR AN UNSPECIFIED INDICATION. ON (B)(6) 2021, AFTER SLEEPING ALL NIGHT, THE CONSUMER NOTED THE APPLICATION SITE WAS BURNING. IT WAS CLARIFIED THAT HER EYES WERE BURNING. HER DAUGHTER NOTED HER EYE LOOKED RED. HER EYES WERE SWELLING, FURTHER CLARIFIED AS SHE HAD SWELLING UNDERNEATH HER EYE WHERE THE EDGE OF THE STRIP WAS. SHE ALSO EXPERIENCED ITCHING INSIDE OF HER EYES, HER EYES WERE RED, SHE HAD A BURNING SENSATION ON THE APPLICATION SITE, HER EYELIDS WERE PURPLE/RED, AND SHE HAD FLUID FILLED BLISTERS. ON AN UNSPECIFIED DATE, SHE CALLED HER EYE DOCTOR. SHE WAS GIVEN EYE DROPS AND ANTIBIOTICS TO APPLY TO THE AREA. SHE DEVELOPED A BLISTER UNDERNEATH HER EYE A COUPLE DAYS LATER. HER SYMPTOMS WERE NOT GETTING ANY BETTER, SO SHE WENT TO AN URGENT CARE ON SATURDAY (B)(6)2021). SHE WAS GIVEN A STEROID SHOT, A STEROID DOSE PACK, AND SHE WAS TOLD TO TAKE BENADRYL (DIPHENHYDRAMINE) AT NIGHT AND ALLEGRA (FEXOFENADINE) DURING THE DAY. AS OF (B)(6) 2021, THE CONSUMER'S REDNESS WAS STILL PRESENT, THE BLISTER WAS HEALING, THE SWELLING WAS RESOLVED, BUT HER EYELID WAS ITCHY AND LOOKED LIKE IT WAS DRY, AND IT WANTED TO PEEL. THE CONSUMER FURTHER CLARIFIED THAT HER SYMPTOMS WERE GETTING BETTER, AND SHE DID NOT HAVE THE FLUID FILLED BLISTERS ANYMORE. NO ADDITIONAL INFORMATION WAS PROVIDED.
ON (B)(6) 2021, A SPONTANEOUS REPORT FROM THE UNITED STATES VIA TELEPHONE REGARDING A (B)(6) YEAR-OLD FEMALE WHO USED A BREATHE RIGHT EXTRA CLEAR NASAL STRIP. MEDICAL HISTORY INCLUDED A PART OF HER KIDNEY WAS REMOVED (NOT FURTHER SPECIFIED). ALLERGIES INCLUDED ANTIBIOTICS AND SEASONAL ALLERGIES. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON (B)(6) 2021, THE CONSUMER APPLIED A BREATHE RIGHT EXTRA CLEAR (LOT NUMBER: 1207617; EXPIRATION DATE NOT PROVIDED) AS DIRECTED ON THE PACKAGE ONE TIME AND WORE IT OVERNIGHT FOR AN UNSPECIFIED INDICATION. ON (B)(6) 2021, AFTER SLEEPING ALL NIGHT, THE CONSUMER NOTED THE APPLICATION SITE WAS BURNING. IT WAS CLARIFIED THAT HER EYES WERE BURNING. HER DAUGHTER NOTED HER EYE LOOKED RED. HER EYES WERE SWELLING, FURTHER CLARIFIED AS SHE HAD SWELLING UNDERNEATH HER EYE WHERE THE EDGE OF THE STRIP WAS. SHE ALSO EXPERIENCED ITCHING INSIDE OF HER EYES, HER EYES WERE RED, SHE HAD A BURNING SENSATION ON THE APPLICATION SITE, HER EYELIDS WERE PURPLE/RED, AND SHE HAD FLUID FILLED BLISTERS. ON AN UNSPECIFIED DATE, SHE CALLED HER EYE DOCTOR. SHE WAS GIVEN EYE DROPS AND ANTIBIOTICS TO APPLY TO THE AREA. SHE DEVELOPED A BLISTER UNDERNEATH HER EYE A COUPLE DAYS LATER. HER SYMPTOMS WERE NOT GETTING ANY BETTER, SO SHE WENT TO AN URGENT CARE ON SATURDAY((B)(6) 2021). SHE WAS GIVEN A STEROID SHOT, A STEROID DOSE PACK, AND SHE WAS TOLD TO TAKE BENADRYL (DIPHENHYDRAMINE) AT NIGHT AND ALLEGRA (FEXOFENADINE) DURING THE DAY. AS OF (B)(6) 2021, THE CONSUMER'S REDNESS WAS STILL PRESENT, THE BLISTER WAS HEALING, THE SWELLING WAS RESOLVED, BUT HER EYELID WAS ITCHY AND LOOKED LIKE IT WAS DRY, AND IT WANTED TO PEEL. THE CONSUMER FURTHER CLARIFIED THAT HER SYMPTOMS WERE GETTING BETTER, AND SHE DID NOT HAVE THE FLUID FILLED BLISTERS ANYMORE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1860492 | BREATHE RIGHT EXTRA CLEAR | NASAL STRIPS | LWF | FOUNDATION CONSUMER BRANDS, LLC | 1207617 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Required Intervention |