NATURA

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE: 9618003.

Description of Event or Problem

THE END USER HAD REPORTED RED, WEEPY, OOZING SKIN UNDER THE MIRROR IMAGE OF THE TAPE COLLAR. SHE HAD SEEN HER OSTOMY NURSE A WEEK EARLIER, WHO STATED THAT IT WAS A FUNGAL INFECTION. SHE HAD BEEN PRESCRIBED AN ORAL ANTIFUNGAL MEDICATION ALONG WITH ANTIFUNGAL POWDER FOR TOPICAL APPLICATION. THE CONSUMER STATED THAT THE IRRITATION HAD NOT IMPROVED AND HAD WORSENED. SHE ALSO MENTIONED THAT SHE HAD LOST TEN POUNDS (LBS) RECENTLY. NO PHOTOGRAPH WAS AVAILABLE AT THAT TIME.

Additional Manufacturer Narrative

CORRECTION: H6: MEDICAL DEVICE PROBLEM CODE: THIS CASE WAS IDENTIFIED AS MISUSE. HOWEVER, WITH THE INITIAL EMDR, A24 (ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM) WAS ADDED. THIS HAS BEEN CORRECTED IN THIS SUPPLEMENTAL EMDR TO A2303. ADDITIONAL INFORMATION: THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION DATABASE. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. INVESTIGATION ACTIONS: CLINICAL EVALUATION: A CLINICAL EVALUATION WAS CONDUCTED BY A CONVATEC'S MEDICAL AFFAIRS SPECIALIST. FROM THE INFORMATION PROVIDED, FUNGAL INFECTION DIAGNOSED BY HEALTHCARE PROFESSIONAL (HCP) AND TREATMENT ADVISED. THE CAUSE OF INFECTION WAS, POTENTIALLY, LINKED TO USER ERROR SPECIFICALLY, USING PRODUCTS LARGER THAN STOMA WHICH LED TO LEAKAGE AND THEN CAUSED INFECTION. STATES SHE HAS ALSO LOST 10LBS RECENTLY. NO DEVICE MALFUNCTION WAS CONFIRMED. THE CASE REMAINS CLASSIFIED AS SEVERITY 4 FOR VIGILANCE TRENDING. DUE TO THE ABSENCE OF PRODUCT SAMPLES AND LOT INFORMATION, A TARGETED PRODUCT INVESTIGATION COULD NOT BE CONDUCTED. CURRENT CONTROLS REVIEW: IN RESPONSE TO THE COMPLAINT AND DUE TO THE ABSENCE OF LOT NUMBER, A COMPREHENSIVE REVIEW OF MANUFACTURING CONTROLS WAS CONDUCTED ACROSS THE RELEVANT PRODUCT: NATURA WFR MOLDABLE CVX 22/45 MM (1X10)US. THIS REVIEW AIMED TO CONFIRM THAT CURRENT CONTROLS ARE SUFFICIENT TO DETECT AND PREVENT THE REPORTED FAILURE MODE. CURRENT QUALITY CONTROLS DURING THE MANUFACTURING PROCESS: BASED ON THE PROCESS INSTRUCTION (PI), THE FOLLOWING TESTS ARE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: TEST METHODS (TM) "VISUAL NONCONFORMITIES - LAMINATED ADHESIVE PRODUCTS": FREQUENCY: HOURLY, SAMPLE QUANTITY: 5 SAMPLES, ACCEPTANCE CRITERIA: ACCEPT = 0/ REJECT = 1. TEST METHODS (TM) "FABRIC COLLAR TO FLANGE WELD ATTACHMENT STRENGTH": FREQUENCY: EVERY 2 HOURS, SAMPLE QUANTITY: 4 SAMPLES PER STATION, ACCEPTANCE CRITERIA: NOT LESS THAN (NLT) 10N POR 1" PER STRIP. "SRP CENTERING ON CONVEX DISC": FREQUENCY: HOURLY, SAMPLE QUANTITY: 5 SAMPLES, ACCEPTANCE CRITERIA: NOT LESS THAN (NLT) 0.040" (1.0 MM) FROM THE OUTER DIAMETER OF THE THERMOFORMED DISC TO THE INNER DIAMETER OF THE SRP KISS CUT COLLAR. "FABRIC COLLAR VISUAL INSPECTION": FREQUENCY: HOURLY, SAMPLE QUANTITY: 5 SAMPLES, ACCEPTANCE CRITERIA: FABRIC COLLAR FREE OF DIRT, TEARS, CUT PUNCTURE LINES, AND HAS A CLEAN CONTOUR CUT. CURRENT QUALITY CONTROLS DURING THE PACKAGING PROCESS: BASED ON THE PROCESS INSTRUCTION (PI), THE FOLLOWING TESTS ARE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: TEST METHODS (TM) "VISUAL NONCONFORMITIES - LAMINATED ADHESIVE PRODUCTS": FREQUENCY: 100% DURING PROCESS, SAMPLE QUANTITY: 100%, ACCEPTANCE CRITERIA: ACCEPT = 0/ REJECT = 1. TEST METHODS (TM) "PACKAGE SEAL INTEGRITY NONCONFORMITIES": FREQUENCY: HOURLY, SAMPLE QUANTITY: 2 BLISTERS PER DIE, ACCEPTANCE CRITERIA: ACCEPT = 0/ REJECT = 1. PROCESS FAILURE MODE EFFECTS ANALYSIS (PFMEA) AND RISK MANAGEMENT: ALL INSPECTIONS AND CONTROLS ARE DOCUMENTED IN PROCESS FAILURE MODE EFFECTS ANALYSIS (PFMEA) ANALYSES FOR MANUFACTURING LINE. THE SEVERITY OF POTENTIAL FAILURE MODES WAS RATED AS 4 (SERIOUS), AND THE OCCURRENCE WAS 1 (REMOTE). ACCORDING TO RISK MANAGEMENT PROCEDURE STANDARD OPERATING PROCEDURE (SOP), THE LIKELIHOOD OF HARM TO THE END USER WAS CONSIDERED HIGHLY UNLIKELY DUE TO THE EFFECTIVENESS OF THE CONTROLS IN PLACE. FINDINGS: BASED ON THE REVIEW OF MANUFACTURING CONTROLS FOR THE PRODUCT LISTED ABOVE, IT WAS CONCLUDED THAT ROBUST QUALITY SYSTEMS ARE IN PLACE TO DETECT AND PREVENT BOTH VISUAL AND FUNCTIONAL FAILURES. ALTHOUGH NO LOT NUMBER WAS IDENTIFIED IN THE COMPLAINT, THE CONTROLS REVIEWED DEMONSTRATE A LOW RISK OF HARM TO THE END USER. THESE CONTROLS ARE DOCUMENTED AND ROUTINELY VERIFIED TO ENSURE PRODUCT INTEGRITY AND PATIENT SAFETY, EVEN IN CASES WHERE TRACEABILITY WAS LIMITED. TREND ANALYSIS: AS PART OF THE INVESTIGATION, A REVIEW WAS CONDUCTED ON "INFECTION REQUIRES PRESCRIPTIVE TREATMENT (E.G. ORAL, IV ANTIBIOTICS, SURGICAL DEBRIDEMENT OR EXCISION)" COMPLAINTS ASSOCIATED WITH PRODUCTS MANUFACTURED ON THE SAME PRODUCTION LINE. THE ANALYSIS COVERED DATA FROM 2024 TO 2026. TWO ADDITIONAL COMPLAINTS WERE FOUND IN DATABASE. HOWEVER, NO LEAKAGE WAS REPORTED IN ANY OF THE CASES, AND NONE OF THE COMPLAINTS WERE RELATED TO INCORRECT SIZE. BASED ON THE DATA REVIEWED, THERE¿S NO INDICATION OF A RECURRING OR SYSTEMIC ISSUE. THE COMPLAINTS SEEM TO BE ISOLATED EVENTS RATHER THAN PART OF A BROADER PATTERN. PERSONNEL NOTIFICATION AND TRAINING: AS PART OF THE INVESTIGATION, THE TEAMS INVOLVED IN THE MANUFACTURING OF THE AFFECTED PRODUCT WERE INFORMED ABOUT THE REPORTED ISSUE. THE GOAL WAS TO RAISE AWARENESS AND REINFORCE THE IMPORTANCE OF INSPECTION PROTOCOLS, ESPECIALLY CONSIDERING THAT NO SPECIFIC LOT NUMBER WAS AVAILABLE. THE NOTIFICATION SESSIONS WERE CARRIED OUT ACROSS ALL SHIFTS, SERVED AS A REMINDER TO REMAIN VIGILANT AND MAINTAIN HIGH STANDARDS IN DAILY OPERATIONS. THIS EFFORT HELPED ENSURE THAT EVERYONE INVOLVED CONTINUES TO FOLLOW ESTABLISHED CONTROLS AND REMAINS ATTENTIVE TO ANY SIGNS OF DEVIATION, EVEN IN CASES WHERE PRODUCT TRACEABILITY WAS LIMITED. ATTACHED FILES ON THE COMPLAINT INVESTIGATION DATABASE: (B)(6) 2026PERSONALNOTIFICATION DATABASE. CONCLUSION: ALTHOUGH NO SPECIFIC LOT NUMBER WAS IDENTIFIED, THE INVESTIGATION INCORPORATED A THOROUGH CLINICAL EVALUATION, A COMPREHENSIVE REVIEW OF MANUFACTURING CONTROLS, TRENDING ANALYSIS OF RELATED COMPLAINTS, AND PERSONNEL AWARENESS EFFORTS. THE CLINICAL EVALUATION CONCLUDED THAT INFORMATION WAS PROVIDED, FUNGAL INFECTION DIAGNOSED BY HEALTHCARE PROFESSIONAL (HCP) AND TREATMENT ADVISED. MANUFACTURING CONTROLS ACROSS THE RELEVANT PRODUCT WERE FOUND TO BE ROBUST, WITH MULTIPLE LAYERS OF INSPECTION AND RISK MITIGATION IN PLACE. NO DEVIATIONS OR SYSTEMIC FAILURES WERE IDENTIFIED. TREND ANALYSIS OF HARM "INFECTION" FROM 2024 TO 2026 REVEALED NO INCREASE OR RECURRING PATTERN ON THIS MANUFACTURING LINE. PERSONNEL INVOLVED IN THE MANUFACTURING PROCESS WERE NOTIFIED TO REINFORCE AWARENESS OF THE POTENTIAL FAILURE MODE AND THE IMPORTANCE OF INSPECTION PROTOCOLS, ENSURING CONTINUED VIGILANCE. INVESTIGATION OUTCOME: NO SYSTEMIC ISSUE WAS DETECTED. THE COMPLAINT APPEARS TO BE AN ISOLATED CASE WITH NO EVIDENCE OF RECURRING PRODUCT FAILURE. BASED ON THE AVAILABLE DATA AND CONTROLS IN PLACE, THE INVESTIGATION OUTCOME WAS INCONCLUSIVE, WITH A LOW RISK OF RECURRENCE. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092, MANUFACTURING SITE: 9618003.

Description of Event or Problem

TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.