SUR-FIT NATURA

Additional Manufacturer Narrative

DEVICE 11 OF 14 BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. 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 FOURTEEN PRE-CUT WAFERS FROM TWO MARKET UNIT BOXES WITH SAME LOT NUMBER HAD OFF CENTERED STARTER HOLE PRIOR TO USE. THIS MADE THE PRODUCT UNUSABLE. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

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 REPORTABLE MALFUNCTION. NO PHOTOGRAPH ASSOCIATED WITH THIS CASE WAS RECEIVED. NO RETURN SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT. BATCH RECORD REVISION RESULTS: LOT 5J00792 WAS MANUFACTURED ON 04/SEP/2025, IN CONVEX 2 PC LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 30/JAN/2026, TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BILL OF MATERIALS (BOM) AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL IDENTIFICATION (ID) 1161271 AND MANUFACTURING ORDER (B)(4). REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. HISTORICAL COMPLAINTS REVIEW: ON 30/JAN/2026, COMPLAINT ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR 5J00792 LOT FOR THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (PRE-CUT ONLY)¿ AND AS RESULT NO ADDITIONAL TYPE 2 COMPLAINTS WERE IDENTIFIED DURING THIS SEARCH AS PER WORK INSTRUCTIONS (WI). HISTORICAL NONCONFORMANCE REVIEW: ON 30/JAN/2026, COMPLAINT ENGINEER RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NON-CONFORMANCE (NC)'S / CORRECTIVE ACTION / PREVENTIVE ACTIONS CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA)(S) ASSOCIATED TO THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (PRE-CUT ONLY)¿ FOR THE LOT NUMBER 5J00792 AND AS RESULT, NO NON-CONFORMANCE (NC)'S / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA)(S) FOR THIS MALFUNCTION WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOT. CURRENT QUALITY CONTROLS: 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: ADHESIVE TO CONVEX DISC CENTERING (VISUAL): NOT LESS THAN 0.095" (2.4MM) FROM ID OF THE ADHESIVE CENTER HOLE TO ID OF THE CONVEX DISC AT ANY POINT. (QUALITY CONTROL) PICTURE FRAME SRP: NOT LESS THAN 0.504" (12.8MM), WIDTH OF THE SRP LEFT AT ANY POINT ON THE PICTURE FRAME. (QUALITY CONTROL) PICTURE FRAME SRP TO CONVEX DISC CENTERING: NOT LESS THAN 0.040" (1.0MM) FROM THE OUTER DIAMETER OF THERMOFORMED DISC TO COLLAR SRP KISS CUT INNER DIAMETER. (QUALITY CONTROL) FREQUENCY: HOURLY SAMPLE QUANTITY: 5 SAMPLES. ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 14 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE OF (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4) WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR LEAKAGE WHICH SHOULD BE 2.5% BASED ON OUR PROCESS INSTRUCTION (PI). IN ADDITION, ALL THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE UNIT, WHICH CONFIRMS THAT THE LOT IS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF 2.5. THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: A REVIEW OF BATCH RECORD WAS COMPLETED AND SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCIES RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. ADDITIONALLY, A REVIEW OF HISTORICAL COMPLAINTS WAS PERFORMED, AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED, AND A REVIEW OF HISTORICAL NONCONFORMANCES SHOWED NO ADDITIONAL NONCONFORMANCES. 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.