SUR-FIT NATURA

Description of Event or Problem

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

Additional Manufacturer Narrative

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. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SEVERE INJURY. REQUESTS WERE PROVIDED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER HOWEVER LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION IN 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 PATIENT PRESENTED WITH A RASH AND WAS TREATED BY THE HEALTHCARE PROFESSIONAL (HCP) WITH ANTIFUNGAL MEDICATION. THIS INFECTION COULD BE A RESULT OF ANY ONGOING TREATMENT, SUCH AS RADIO/CHEMOTHERAPY. HYDROCOLLOID MASS COMPOSITION THE HYDROCOLLOID ADHESIVE MASS USED IN THE PRODUCT WAS FORMULATED USING A BLEND OF ELASTOMERS, ADHESIVE COMPONENTS, AND HYDROCOLLOID POLYMERS DESIGNED TO PROVIDE SECURE ADHESION AND MINIMIZE SKIN IRRITATION DURING INTENDED USE. THESE MATERIALS WORK SYNERGISTICALLY TO CREATE THE HYDROCOLLOID ADHESIVE MATRIX, WHICH WAS ENGINEERED TO MAINTAIN A PROTECTIVE SEAL, ABSORB MOISTURE, AND PROVIDE GENTLE ADHESION TO THE PERISTOMAL SKIN. CURRENT QUALITY CONTROLS DURING THE INCOMING INSPECTION PROCESS: ALL RAW MATERIALS LISTED ABOVE UNDERGO A DOCUMENTED INCOMING INSPECTION PROCESS PRIOR TO RELEASE FOR USE IN MANUFACTURING. THIS PROCESS INCLUDES: VERIFICATION OF SUPPLIER DOCUMENTATION, INCLUDING CERTIFICATES OF ANALYSIS (COA) CONFIRMING COMPLIANCE WITH APPLICABLE SPECIFICATIONS. VISUAL INSPECTION FOR CONTAMINATION, DISCOLORATION, MOISTURE EXPOSURE, OR ANY PHYSICAL DEFECTS. PACKAGING INTEGRITY ASSESSMENT, ENSURING THAT CONTAINERS ARE INTACT, PROPERLY SEALED, AND FREE FROM DAMAGE. LOT IDENTIFICATION AND TRACEABILITY VERIFICATION, CONFIRMING THAT RECEIVED MATERIALS MATCH THE APPROVED PURCHASE ORDER AND MEET ALL DEFINED ACCEPTANCE CRITERIA. QUALITY SYSTEM RELEASE, PERFORMED ONLY AFTER ALL INSPECTION CHECKPOINTS ARE SUCCESSFULLY COMPLETED. THIS INCOMING INSPECTION PROCESS ENSURES THAT ALL MATERIALS USED IN THE HYDROCOLLOID MASS FORMULATION MEET ESTABLISHED QUALITY AND SAFETY SPECIFICATIONS AND ARE IN ACCEPTABLE CONDITION PRIOR TO INCORPORATION INTO THE FINAL DEVICE. CURRENT QUALITY CONTROLS DURING THE MANUFACTURING PROCESS: SINCE THE COMPLAINT DID NOT INCLUDE A SPECIFIC LOT NUMBER, THE INVESTIGATION USED THE PART NUMBER AND PRODUCT DESCRIPTION PROVIDED TO IDENTIFY THE CORRESPONDING MANUFACTURING LINE, THE RELEVANT PRODUCT SURFIT NAT S4S D/HESIVE WFR 45MM(1X10)US. BASED ON THIS INFORMATION, PROCESS INSTRUCTION (PI), CORRESPONDING TO THE MLK, WAS IDENTIFIED. THE ASSOCIATED IN PROCESS CONTROLS WERE REVIEWED TO CONFIRM THAT THE CONTROLS ESTABLISHED FOR THIS MANUFACTURING LINE ARE ADEQUATE TO DETECT AND PREVENT THE REPORTED FAILURE MODE. TEST METHODS (TM) "PACKAGE SEAL INTEGRITY NONCONFORMITIES" - METHOD: FREQUENCY: CONTINUOUS VISUAL INSPECTIONS SAMPLE QUANTITY: 5 SAMPLES ACCEPTANCE CRITERIA: ACCEPT = 0/ REJECT = 1. TEST METHODS (TM) "FLANGE WELD INTEGRITY - ADHESIVE WAFERS" - METHOD: FREQUENCY: HOURLY SAMPLE QUANTITY: 6 SAMPLES PER STATION ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. RISK MANAGEMENT DOCUMENT: ALL INSPECTIONS AND CONTROLS ARE DOCUMENTED IN DHF RSK ANALYSES FOR THE DEVICE SPECIFICATION. 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. ONE (1) ADDITIONAL COMPLAINT WAS FOUND IN DATABASE. THE REVIEW CONFIRMS THAT THE EVENTS ARE CLINICALLY HETEROGENEOUS AND THE ASSOCIATED INVESTIGATIONS, BASED ON THE INFORMATION PROVIDED, DID NOT IDENTIFY A CONSISTENT DEVICE DEFECT OR MALFUNCTION PATTERN ACROSS THE RECORDS. 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. FOR FURTHER DETAILS, REFER TO THE ATTACHMENT 13 FEB 2026 - PERSONAL NOTIFICATION - IN 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, A SMALL LESION IDENTIFIED PRODUCING PUSS, ON EXAMINATION BY HEALTHCARE PROFESSIONAL (HCP), ANTIBIOTIC TREATMENT WAS ADVISED AND WORKED EFFECTIVELY. CT SCAN CARRIED OUT WITH NO SIGN OF AN ABSCESS DETECTED. 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.

Additional Manufacturer Narrative

THE EVENT IS CONSIDERED MISUSE. END USER HAD ALLERGIC CONTACT DERMATITIS WITH ITCHING, BURNING SENSATION AND RASH FROM (B)(6) 2025, HOWEVER THE PATIENT CONTINUED TO USE THE PRODUCT TILL (B)(6) 2025. 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 SUSPECTED ALLERGIC CONTACT DERMATITIS CASE HAD BEEN DETERMINED TO BE A COMPLAINT. THE CONSUMER AND HIS WIFE REPORTED A PERISTOMAL RASH WITH REDNESS, ITCHING, AND BURNING LOCATED IN A MIRROR IMAGE OF THE SIDES AND BOTTOM OF HIS SKIN BARRIER. HE STATED THAT HE HAD BEEN USING THE PRODUCT FOR AT LEAST TWO YEARS; HOWEVER, THE RASH BEGAN DEVELOPING IN (B)(6) 2025 AND DID NOT RESOLVE WITH RECOMMENDED TREATMENTS. THE CONSUMER REPORTED SEEKING ASSESSMENT FROM A LOCAL HEALTHCARE PROFESSIONAL IN (B)(6) 2025, WHO INITIALLY TREATED FOR CANDIDIASIS WITH TWO DOSES OF ORAL ANTIFUNGAL, POSSIBLY FLUCONAZOLE, THREE DAYS APART, THOUGH THIS COULD NOT BE CONFIRMED. THE HEALTHCARE PROFESSIONAL ALSO ADVISED CRUSTING WITH ANTIFUNGAL POWDER (NYSTATIN) AND A BARRIER WIPE. NO IMPROVEMENT WAS NOTED, SO THE CONSUMER FOLLOWED UP WITH THE CANCER CENTER OSTOMY TEAM ABOUT A MONTH LATER. ACCORDING TO THE CONSUMER, THE HEALTHCARE TEAM SUSPECTED FOLLICULITIS AND PRESCRIBED CEPHALEXIN FOR ONE WEEK ALONG WITH TOPICAL TREATMENT USING HYPOCHLOROUS ACID WOUND CLEANSER ON THE PERISTOMAL SKIN. MINIMAL IMPROVEMENT WAS OBSERVED, LEADING THE CONSUMER TO CONSULT A THIRD HEALTHCARE PROFESSIONAL TEAM AT OSTOMY CLINIC IN HIS LOCAL TOWN, WHO SUSPECTED ALLERGIC CONTACT DERMATITIS TO THE ADHESIVE IN HIS SKIN BARRIER. THE CONSUMER REPORTED NO URINE LEAKAGE AND NO REDNESS OR IRRITATION BENEATH HIS BARRIER RING AROUND THE STOMA, BUT THE RASH WAS LOCATED IN THE AREA OF THE MASS AND NON-TAPE COLLAR PORTION OF THE BARRIER. HE WAS TRANSITIONED TO A SOFT CONVEX ONE-PIECE UROSTOMY POUCH. THE CONSUMER REPORTED THAT ITCHING AND BURNING SUBSIDED AFTER DISCONTINUING THE COMPANY'S SKIN BARRIER. NO HOSPITALIZATION WAS REQUIRED, AND PRESCRIPTION MEDICATIONS PROVIDED INCLUDED ORAL ANTIFUNGAL AND ANTIBIOTICS. THE CONSUMER DISCONTINUED USE OF THE ORIGINAL PRODUCT AS OF (B)(6) 2025. NO LABORATORY TESTING WAS PERFORMED, AND THERE WAS NO BLEEDING OR TISSUE DAMAGE REPORTED. NO PHOTO WAS AVAILABLE AT THE TIME.