BAND AID BRAND ADHESIVE BANDAGES WATERPROOF CLEAR
Report
- Report Number
- 2214133-2026-00004
- Event Type
- Injury
- Date Received
- March 20, 2026
- Date of Event
- March 8, 2026
- Report Date
- March 20, 2026
- Manufacturer
- KENVUE BRANDS, LLC
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
KENVUE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH KENVUE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, KENVUE OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, KENVUE, OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IN AUGUST 2023 JOHNSON & JOHNSON¿S CONSUMER HEALTH BUSINESS SEPARATED FROM JOHNSON & JOHNSON, AND WE BECAME AN INDEPENDENT PUBLIC COMPANY, KENVUE. AS PART OF OUR ONGOING EVOLUTION, KENVUE UPDATED THE NAME OF ITS US OPERATING COMPANY, JOHNSON & JOHNSON CONSUMER INC. (¿JJCI¿) TO ¿KENVUE BRANDS LLC¿ ON OCTOBER 28, 2024. KENVUE RECENTLY MOVED TO ITS NEW CORPORATE HEADQUARTERS IN SUMMIT NJ. ITS PREVIOUS CORPORATE HEADQUARTERS WAS 199 GRANDVIEW ROAD, SKILLMAN, NJ 08558. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A4, A5 AND A6: PATIENT WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND ADHESIVE BANDAGES WATERPROOF CLEAR SPOT (B)(4) CT USA 381372025267 381372025267USA, LOT NUMBER ¿ NI. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI IS NA FOR THIS SUBMISSION. UDI: (B)(4), UPC #381372025267. EXPIRATION DATE: NA LOT # NI D9: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. H6: E172003 - CONSUMER ALLEGED "ALLERGIC DERMATITIS (ITCHY, RED RASH, SWELLING AND BUMPY)". E2402 - CONSUMER "MISUSE/OFF-LABEL USE - INTENTIONAL". THE CONSUMER PLACED THE PRODUCT ON A ¿A TINY SKIN TAG ON NECK¿ (INTERPRETED AS MISUSE) AND REPORTED THAT THE NEXT MORNING IT WAS ¿VERY ITCHY¿, ¿RED¿, ¿SWELLING¿ AND ¿BUMPY¿ AT THE SITE OF APPLICATION AND THAT ¿BAND-AID STICKY CAUSED ITCHY RED RADH (INTERPRETED AS RASH) AROUND SKIN TAG¿. CONSUMER WENT TO URGENT CARE AND IT WAS REPORTED THAT THE ¿URGENT CARE PROVIDER PRESCRIBED MEDICATION (TO APPLY 2 TIMES DAILY) FOR ALLERGIC CONTACT DERMATITIS¿ (INTERPRETED AS HCP DIAGNOSIS, CODED TO CONTACT DERMATITIS DUE TO CODING LIMITATION; SUBSUMED ITCHY, RED RASH, SWELLING AND BUMPY¿). BASED ON AVAILABLE INFORMATION, NO IME, NO HOSPITALIZATION, NO SIGNIFICANT INTERVENTION REPORTED AND NO OTHER SERIOUSNESS CRITERIA MET. IF ADDITIONAL INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
A 52-YEAR-OLD FEMALE CONSUMER REPORTED AN ADVERSE EVENT WHILE USING BAND AID BRAND ADHESIVE BANDAGE WATERPROOF CLEAR SPOT. THE CONSUMER PLACED THE PRODUCT ON A TINY SKIN TAG ON NECK AND REPORTED THAT THE NEXT MORNING IT WAS VERY ITCHY, RED, SWELLING AND BUMPY AT THE SITE OF APPLICATION AND THAT BAND-AID STICKY CAUSED ITCHY RED RADH (INTERPRETED AS RASH) AROUND SKIN TAG. CONSUMER WENT TO URGENT CARE AND IT WAS REPORTED THAT THE URGENT CARE PROVIDER PRESCRIBED UNKNOWN MEDICATION (TO APPLY 2 TIMES DAILY) FOR ALLERGIC CONTACT DERMATITIS. CONSUMER STATED THAT HER SYMPTOMS HAVE IMPROVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 716018 | BAND AID BRAND ADHESIVE BANDAGES WATERPROOF CLEAR | TAPE AND BANDAGE, ADHESIVE | KGX | KENVUE BRANDS, LLC | 381372025267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Required Intervention |