Additional Manufacturer Narrative · 0
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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. D4: 510(K) EXEMPT DEVICE I COMPLAINT. UDI: (B)(4). UPC #: 381370044246. EXPIRATION DATE: 11-JUN-2026. LOT # 230612. 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 JUNE 12, 2023. RAW MATERIAL AND COMPONENT RECORDS WERE REVIEWED AND WERE FOUND ACCEPTABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE FOLLOW-UP #1 MEDWATCH, AN ADDITIONAL FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS IS ONE OF TWO MED-WATCH FOLLOW-UPS (BAB 02) BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCHES 1000599868-2025-00005 & MEDWATCH 1000599868-2025-00006. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH FOLLOW-UP.