SUR-FIT NATURA

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. REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. 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 ON ANTICOAGULATION MEDICATION AND WRONG SIZED APERTURE ON THE BASEPLATE WAS USED. THE BLEEDING WAS POTENTIALLY ATTRIBUTED TO CLINICAL MISINDICATION, SPECIFICALLY THE USE OF A PRODUCT WITH AN APERTURE SMALLER THAN THE PATIENT¿S STOMA, RESULTING IN BLEEDING AT THE MUCOCUTANEOUS JUNCTION. THE PATIENT ESTIMATED HER STOMA SIZE TO BE COMPARABLE TO THAT OF A PENNY (APPROXIMATELY 20¿21 MILLI METRE (MM)), WHILE THE PRODUCT USED WAS DESIGNED FOR A STOMA SIZE OF 19 MM. THE PATIENT WAS ADVISED TO PERFORM AN ACCURATE STOMA MEASUREMENT, AND A PRODUCT ONE SIZE LARGER WAS RECOMMENDED BASED ON THE ESTIMATED DIMENSIONS. THIS CASE REMAINS CLASSIFIED AS SEVERITY 4 FOR VIGILANCE TRENDING PURPOSES. 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: SURFIT NATURA WFR CVX 19/45MM (1X10PK) US, ICC: 413179. 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" (1.0MM) 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. RISK MANAGEMENT DOCUMENT: ALL INSPECTIONS AND CONTROLS ARE DOCUMENTED IN DHF ANALYSES FOR THE DEVICE SPECIFICATION. THE SEVERITY OF POTENTIAL FAILURE MODES WAS RATED AS 2 (MINOR), 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. TREND ANALYSIS: AS PART OF THE INVESTIGATION, A REVIEW WAS CONDUCTED ON "BLEEDING", ESPECICALLY ASSOCIATED TO THE MALFUNCTION ¿CLINICAL MISINDICATION, ENDUSER IS USING IMPROPER DEVICE FOR THEIR MEDICAL CONDITION AND/OR KNOWN RISK FACTORS. FOR EXAMPLE: CONVEX WITH HERNIA OR KNOWN SENSITIVITIES TO THE PRODUCT.¿ FOR COMPLAINTS ASSOCIATED WITH PRODUCTS MANUFACTURED ON THE SAME PRODUCTION LINE. THE ANALYSIS COVERED DATA FROM 2024 TO 2026. TWO (2) ADDITIONAL COMPLAINTS WERE FOUND. HOWEVER, 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. ATTACHED FILES ON THE COMPLAINT INVESTIGATION: 24 FEB 2026 PERSONAL NOTIFICATION CONCLUSION: BASED ON THE REVIEW OF MANUFACTURING CONTROLS FOR THE PRODUCT LISTED ABOVE, IT IS 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. 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 THE PATIENT WAS ON ANTICOAGULATION MEDICATION AND WRONG SIZED APERTURE ON THE BASEPLATE WAS USED. 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 "BLEEDING" 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 IS INCONCLUSIVE, WITH A LOW RISK OF RECURRENCE. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). 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.

Additional Manufacturer Narrative

D10: CONTINUED LIST OF CONCOMITANT PRODUCTS: MONTELUKAST 10 MG, CETIRIZINE 10 MG, ROSUVASTATIN 10 MG, FLUOXETINE 20 MG, FUROSEMIDE 20 MG, LEVOTHYROXINE 50 MCG, METOPROLOL SUCCINATE XL 25 MG, ONDANSETRON 4MG AND POTASSIUM CHLORIDE 10 MEQ, MAGNESIUM GLYCINATE GUMMIES 200 MG PER GUMMY, ACETAMINOPHEN PRN, ELDERBERRY SUPPLEMENT, HAIR/SKIN/NAIL GUMMIES APPLE CIDER VINEGAR SUPPLEMENT. THE EVENT IS CONSIDERED AS MISUSE SINCE THE END USER HAD ILEOSTOMY, UNABLE TO STATE STOMA SIZE, ESTIMATES PENNY COIN SIZE (APPROX. 20-21 MM), AND PRODUCT USED HAD STOMA SIZE RANGE OF 19MM. 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 REPORTED THAT INTERMITTENT BLEEDING AND MUCOCUTANEOUS JUNCTION IRRITATION OCCURRED FROM MUCOCUTANEOUS JUNCTION AT THE 6 O'CLOCK POSITION AND DISTAL EDGE BY USING COMPANY'S KNOWN WAFER. NO VISIBLE LACERATION TO STOMA OR SKIN. THE PRODUCT WAS USED ON PATIENT FOR THREE DAYS. SHE STATED NORMALLY, IT WAS JUST A SMALL AMOUNT. HOWEVER, APPROXIMATELY 2 MONTHS AGO, SHE EXPERIENCED AN EPISODE OF SQUIRTING BLOOD THAT SOAKED THROUGH WASHCLOTHS. AT THIS TIME, SHE WENT TO THE EMERGENCY ROOM. SHE DID NOT RECALL IF ANY LAB WORK WAS PERFORMED. HOWEVER, SHE SAID THAT AREA WAS TREATED TO STOP THE BLEEDING. SHE DID NOT RECALL WHAT WAS USED BUT BASED ON HER DESCRIPTION IT MAY HAD BEEN SILVER NITRATE. THE CONSUMER DID NOT USE ADHESIVE REMOVER IN THE PROCESS OF REMOVING THE PRODUCT. SHE DENIED DIFFICULTY IN REMOVING THE PRODUCT. SINCE THEN, SHE HAD INTERMITTENT ISSUES WITH BLEEDING THAT ONLY OCCUR WHEN SHE WAS REMOVING THE PRODUCT AND CLEANSING THE SKIN, NONE HAVE REQUIRED MORE THAN HELD PRESSURE TO RESOLVE. SHE DENIED ANY DILATED BLOOD VESSELS IN THE AREA. AT ONE TIME, SHE THOUGHT SHE SAW A HOLE AT THE JUNCTION BUT HAD NOT SEEN IT AGAIN AND NOBODY ELSE HAS SEEN IT. IT WAS THOUGHT THAT SHE MIGHT HAVE TOO SMALL OF A BARRIER, BUT THE STOMA HAD NOT BEEN MEASURED. SHE GAVE ESTIMATED SIZE OF STOMA AS COMPARISON TO A PENNY COIN SIZE APPROXIMATELY 20-21 MM. NO PHOTOGRAPH IS AVAILABLE AT THIS TIME.