NATURA

Additional Manufacturer Narrative

DEVICE 2 OF 3 BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE WAS A PHOTOGRAPH ASSOCIATED WITH THIS CASE AND IN THIS, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. BATCH RECORD REVISION RESULTS: LOT 5A01756 WAS MANUFACTURED ON 08/JAN/2025, IN CONVEX 2 PC LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 02/FEB/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) 1156500 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 02/FEB/2026, COMPLAINT INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR 5A01756 LOT FOR THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (MOLDABLE ONLY)¿ AND AS RESULT NO ADDITIONAL REPORTABLE COMPLAINTS WERE IDENTIFIED DURING THIS SEARCH AS PER WORK INSTRUCTIONS (WI). HISTORICAL NONCONFORMANCE REVIEW: ON 02/FEB/2026, COMPLAINT INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (MOLDABLE ONLY)¿ FOR THE LOT NUMBER 5A01756 AND AS RESULT, NO NONCONFORMANCE / 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 (NLT) 0.095" (2.4 MILLIMETER (MM) FROM ID OF THE ADHESIVE CENTER HOLE TO ID OF THE CONVEX DISC AT ANY POINT. (QC TOOL) PICTURE FRAME SRP: NOT LESS THAN (NLT) 0.504" (12.8MM), WIDTH OF THE SRP LEFT AT ANY POINT ON THE PICTURE FRAME. (QC TOOL) PICTURE FRAME SRP TO CONVEX DISC CENTERING: NOT LESS THAN (NLT) 0.040" (1.0 MILLIMETER (MM) FROM THE OUTER DIAMETER OF THERMOFORMED DISC TO COLLAR SRP KISS CUT INNER DIAMETER. (QC TOOL) FREQUENCY: HOURLY SAMPLE QUANTITY: 5 SAMPLES. ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 3 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE OF (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4) WHICH WAS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR LEAKAGE WHICH SHOULD BE 2.5% BASED ON OUR STANDARD OPERATING PROCEDURE (SOP). IN ADDITION, ALL THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE UNIT, WHICH CONFIRMS THAT THE LOT WAS UNLIKELY TO BREACH AN AQL OF 2.5. THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT WAS WELL WITHIN OUR ACCEPTED 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). 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 THE COMPANY'S KNOWN MOLDABLE WAFER'S STARTER HOLE WAS OFF CENTERED PRIOR TO USE. HE FELT THIS MADE THE PRODUCT UNUSABLE. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

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. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE WAS A PHOTOGRAPH ASSOCIATED WITH THIS CASE AND IN THIS, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. BATCH RECORD REVISION RESULTS: LOT 5A01756 WAS MANUFACTURED ON 08/JAN/2025, IN CONVEX 2 PC LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 02/FEB/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) 1156500 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 02/FEB/2026, COMPLAINT INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR 5A01756 LOT FOR THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (MOLDABLE ONLY)¿ AND AS RESULT NO ADDITIONAL REPORTABLE COMPLAINTS WERE IDENTIFIED DURING THIS SEARCH AS PER WORK INSTRUCTIONS (WI). HISTORICAL NONCONFORMANCE REVIEW: ON 02/FEB/2026, COMPLAINT INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (MOLDABLE ONLY)¿ FOR THE LOT NUMBER 5A01756 AND AS RESULT, NO NONCONFORMANCE / 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 (NLT) 0.095" (2.4MM) FROM ID OF THE ADHESIVE CENTER HOLE TO ID OF THE CONVEX DISC AT ANY POINT. (QC TOOL) PICTURE FRAME SRP: NOT LESS THAN (NLT) 0.504" (12.8MM), WIDTH OF THE SRP LEFT AT ANY POINT ON THE PICTURE FRAME. (QC TOOL) PICTURE FRAME SRP TO CONVEX DISC CENTERING: NOT LESS THAN (NLT) 0.040" (1.0MM) FROM THE OUTER DIAMETER OF THERMOFORMED DISC TO COLLAR SRP KISS CUT INNER DIAMETER. (QC TOOL) FREQUENCY: HOURLY SAMPLE QUANTITY: 5 SAMPLES. ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 3 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE OF (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4) PERCENT WHICH WAS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR LEAKAGE WHICH SHOULD BE 2.5 PERCENT 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 WAS UNLIKELY TO BREACH AN AQL OF 2.5 PERCENT. THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT WAS WELL WITHIN OUR ACCEPTED 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). 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.