BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES
Report
- Report Number
- 2214133-2026-00002
- Event Type
- Injury
- Date Received
- February 13, 2026
- Report Date
- February 13, 2026
- Manufacturer
- KENVUE BRANDS, LLC
- Product Code
- NAD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 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 & AMP; 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 & AMP; 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. A1, A2, A3, A4, A5, A6: PATIENT IDENTIFIER, AGE, SEX, WEIGHT, ETHNICITY AND RACE WERE NOT PROVIDED FOR REPORTING. D1, D2, D3, D4: THIS REPORT IS FOR ONE (1) BAND AID BRAND KIZU POWER PAD (KPP) LARGE 6CT AP 4901730021913 4901730021913APB. LOT NUMBER - NI. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (BAND AID BRAND HYDROSEAL BANDAGES ALL PURPOSE 1CT USA 381371175338 8137117533USA). D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI, LOT NUMBER AND EXPIRATION DATE ARE NOT AVAILABLE FOR REPORTING. 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. E1720 ¿ REFERS TO REPORTED & QUOT; IRRITATION¿ & QUOT. E040203¿ REFERS TO REPORTED & QUOT; THE SKIN WHERE IT WAS APPLIED LOOKED LIKE A BURN & QUOT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
AN ADVERSE EVENT WAS REPORTED BY THE CONSUMER FOR BAND AID BRAND KIZU POWER PAD (KPP) LARGE 6CT BANDAGE. THE CONSUMER APPLIED THE BAND-AID FOR A MINOR WOUND STABBED WITH A SCREWDRIVER. IT WAS REPORTED THAT FOLLOWING THREE DAYS OF USING THE PRODUCT THE CONSUMER STARTED TO FEEL IRRITATING AT THE SITE OF APPLICATION AND THAT THE SITE LOOKED LIKE A BURN. CONSUMER VISITED A DERMATOLOGIST AND APPLIED THE PRESCRIBED TOPICAL MEDICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391684 | BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES | DRESSING, WOUND, OCCLUSIVE | NAD | KENVUE BRANDS, LLC | 4901730021913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |