BAND AID BRAND FLEXIBLE FABRIC DECORATED ADHESIVE BANDAGES
Report
- Report Number
- 1000599868-2025-00008
- Event Type
- Injury
- Date Received
- September 9, 2025
- Date of Event
- August 19, 2025
- Report Date
- October 7, 2025
- Manufacturer
- KENVUE
- Product Code
- KGX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
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 AND ADMISSION THAT THE DEVICE, KENVUE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IN (B)(6) 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 (B)(6) 2024. KENVUE RECENTLY MOVED TO ITS NEW CORPORATE HEADQUARTERS IN SUMMIT NJ. ITS PREVIOUS CORPORATE HEADQUARTERS WAS (B)(6). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A4, A5, A6: WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4; THIS REPORT IS FOR (1) BAND AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC TIE DYE ASSORTED 100CT USA (B)(4), LOT #250114. D4: 510(K) EXEMPT, DEVICE I COMPLAINT. UDI NOT REQUIRED. UDI # (B)(4). UPC # (B)(4). LOT # 250114. EXPIRATION DATE: NA. 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 AT THIS TIME; NO CONCLUSION, AT THIS TIME, COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. H6: E172002 ALSO REFERS TO THE CONSUMER ALLEGED CELLULITIS (ITCHING, DRAINAGE BLISTERS, LEFT CHEEK SWOLLEN, LEFT EYE WAS SWOLLEN, PARTIALLY CLOSED). E0402 ALSO REFERS TO THE CONSUMER ALLEGED MISUSE/OFF-LABEL USE OF PRODUCT CONSUMER USED THE PRODUCT TO COVER ¿A CANCER ON HER NOSE¿ (INTERPRETED AS MISUSE). IT WAS REPORTED THAT THE CONSUMER HAD A ¿SEVERE ALLERGY TO LATEX¿ AND THAT FOLLOWING USE OF PRODUCT SHE HAD A ¿SERIOUS MEDICAL REACTION¿/¿SEVERE LATEX REACTION¿ WITH SWELLING AND BLISTERS AT THE SITE OF APPLICATION. BASED ON OVERALL DETAILS AVAILABLE, EVENTS INTERPRETED AS APPLICATION SITE ALLERGY (SUBSUMED SWELLING) AND APPLICATION SITE BLISTER. IT WAS ALSO REPORTED THAT THE CONSUMER HAD BEEN ¿GOING TO THE EMERGENCY ROOM FOR 7 DAYS TO GET IV ANTIBIOTIC, STEROIDS AND BENADRYL¿; AS CONSUMER UNDERWENT AN INTRAVENOUS INTERVENTION WHICH WAS CONSIDERED MEDICALLY SIGNIFICANT, CASE ASSESSED AS SERIOUS. IT WAS REPORTED, ALLERGIC REACTION TURNED INTO CELLULITIS AND HALF OF FACE WAS SWOLLEN. BASED ON THIS INFORMATION EVENT RECODED TO CELLULITIS (BLISTER, SWELLING SUBSUMED). PRURITUS, SWELLING, AND BLISTERS MAY BE SYMPTOMS OF EITHER CELLULITIS OR ALLERGIC REACTION. A MEANINGFUL MEDICAL ASSESSMENT IS PRECLUDED BY THE LIMITED INFORMATION ON THE STATUS OF APPLICATION SITE PRIOR TO PRODUCT USE, CONCURRENT MEDICATIONS, CLEAR HCP DIAGNOSIS, AND/OR LABORATORY TEST RESULTS SUPPORTING THE ALLEGED CELLULITIS/ALLERGIC REACTION. FURTHERMORE, THIS CASE IS CONFOUNDED BY THE PRESENCE OF CANCER TO WHICH THE PRODUCT WAS APPLIED OVER. REVIEW OF RECORDS INDICATE THAT THE BANDAGE MATERIALS AND WRAPPERS MADE BY BAND-AID ARE NOT MADE WITH NATURAL RUBBER LATEX. THE PRODUCTS DO NOT CONTAIN NATURAL RUBBER LATEX. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
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 AND 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. B5: CONSUMER REPORTED ADDITIONAL CLARIFYING INFORMATION. H6: E0402 ALSO REFERS TO THE CONSUMER ALLEGED HYPERSENSITIVITY/ALLERGIC REACTION (SUBSUMED MASSIVE ITCHING). ADDITIONAL INFORMATION REVIEWED. REPORTED BLINDNESS IN EYE ASSESSED AS MEDICAL HISTORY AND NOT ATTRIBUTABLE TO PRODUCT USE OR REPORTED EVENTS CELLULITIS AND ALLERGIC REACTION. THE CONSUMER DID NOT PROVIDE SPECIFIC INFORMATION ON WHETHER HER HISTORY OF BLINDNESS IS TRANSIENT, PERMANENT OR JUST VISUAL IMPAIRMENT. THE PATIENT CONTACTED AN ALLERGIST BUT DID NOT PROVIDE INFORMATION ABOUT THE DIAGNOSIS. CONSUMER REPORTED NOSE SLOUGHING (SUBSUMED UNDER CELLULITIS- (ITCHING, DRAINAGE BLISTERS, LEFT CHEEK SWOLLEN, LEFT EYE WAS SWOLLEN, PARTIALLY CLOSED, STAPH INFECTION). AS PER ADDITIONAL INFORMATION RECEIVED IT WAS REPORTED THAT CONSUMER DEVELOPED ¿MASSIVE ITCHING¿ AND EXPERIENCED A ¿SEVERE ALLERGIC REACTION¿ THUS EVENT OF APPLICATION SITE ALLERGY WAS CONSIDERED (SUBSUMED ITCHING). CONSUMER REPORTED ABOUT DEVELOPING ¿STAPH INFECTION¿ WHICH WAS CONSIDERED TO BE A REFERENCE TO THE ALREADY REPORTED CELLULITIS AND THUS SUBSUMED; ¿PEELING LAYERS¿ WAS ALSO SUBSUMED IN THE EVENT OF CELLULITIS. IT WAS AGAIN MENTIONED THAT THAT ¿SHE HAD 7 DAYS OF OUT PATIENT TREATMENT AT HOSPITAL AS IT WAS ALL IV¿; AS INTRAVENOUS INTERVENTION WAS PERFORMED, EVENT OF APPLICATION SITE ALLERGY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #2 MEDWATCH, AN ADDITIONAL FOLLOW- UP MEDWATCH WILL BE FILED AS APPROPRIATE.
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 AND 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. H2, H4, H6: DEVICE HISTORY RECORDS REVIEW WAS COMPLETED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND PRODUCT WAS MANUFACTURED PER SPECIFICATION. THE PRODUCT WAS MANUFACTURED ON JANUARY 14, 2025. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW- UP MEDWATCH WILL BE FILED AS APPROPRIATE.
A 69-YEAR-OLD FEMALE CONSUMER REPORTED USING BAND AID BRAND ADHESIVE BANDAGE FLEXIBLE FABRIC TIE DYE ASSORTED TO COVER CANCER ON HER NOSE. IT WAS REPORTED THAT THE CONSUMER HAD A SEVERE ALLERGY TO LATEX AND FOLLOWING USE OF THE PRODUCT SHE HAD A SERIOUS MEDICAL REACTION WHICH INCLUDED SEVERE ITCHING, LEFT SIDE OF FACE SWELLING INCLUDING LEFT EYE IS PARTIALLY CLOSED SHUT FROM SWELLING AND BLISTERING WHERE THE PRODUCT CONTACTED HER SKIN. THE CONSUMER REPORTED TRAVEL TO AND FROM THE HOSPITAL EMERGENCY ROOM FOR SEVEN DAYS FOR TREATMENT WHICH CONSISTS OF STEROIDS, BENADRYL, AND INTRAVENOUS ANTIBIOTICS AS THE CONSUMER STATED HER REACTION TURNED INTO CELLULITIS ON HER FACE. THE CUSTOMER REPORTED HER CONDITION IS SLOWLY GETTING BETTER DUE TO RECEIVING BENADRYL, STEROIDS, AND ANTIBIOTICS INFUSIONS TREATMENTS.
CONSUMER REPORTED ADDITIONAL CLARIFYING INFORMATION. CONSUMER STATED SHE WAS TREATED WITH ANTIBIOTICS FOR HER ALLERGIC REACTION. CONSUMER STATED THAT SHE DEVELOPED BLISTERS ON HER NOSE, MASSIVE ITCHING, PEELING LAYERS ARE FALLING OFF AND A STAPH INFECTION. CONSUMER ALLEGED THAT SHE TRAVELED FOR 7 DAYS FOR OUTPATIENT TREATMENT, BUT WAS NOT ADMITTED TO THE HOSPITAL; ALL TREATMENT WAS DONE WITH IV THERAPY. SHE STATED SHE IS ALLERGIC TO THE WORLD. CONSUMER STATED MEDICAL HISTORY OF BLINDNESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2418935 | BAND AID BRAND FLEXIBLE FABRIC DECORATED ADHESIVE BANDAGES | TAPE AND BANDAGE, ADHESIVE | KGX | KENVUE | 381372025090 | 250114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Required Intervention |