DUODERM
Report
- Report Number
- 9618003-2025-03007
- Event Type
- Malfunction
- Date Received
- November 19, 2025
- Report Date
- November 6, 2025
- Manufacturer
- CONVATEC DOMINICAN REPUBLIC INC
- Product Code
- NAD
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
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. B5: ADDITIONAL PHOTOGRAPH HAS BEEN RECEIVED ON 28 NOV 2025. BATCH RECORD REVIEW: LOT 3F06123 WAS MANUFACTURED 06/JUL/2023, IN BODOLAY LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 13/NOV/2025, 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) 1000854 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. THE REPORTED MALFUNCTION COULD BE GENERATED DURING THE MANUFACTURING PROCESS OF THE FINAL LINE, THEREFORE NO FURTHER BATCH RECORD REVIEW OF THE SUBASSEMBLY LOTS WAS REQUIRED. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE WERE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. HISTORICAL COMPLAINTS REVIEW: ON 13/NOV/2025, COMPLAINTS ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 3F06123 LOT FOR THE MALFUNCTION ¿PRIMARY PACK (STERILE PRODUCTS) EXHIBITS EXTERNAL CONTAMINATION (E.G. WATER MARKS, STAINS).¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 13/NOV/2025, COMPLAINTS ENGINEER RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿PRIMARY PACK (STERILE PRODUCTS) EXHIBITS EXTERNAL CONTAMINATION (E.G. WATER MARKS, STAINS).¿ DEFECT FOR THE LOT NUMBER 3F06123 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 WERE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: TEST METHODS (TM) "STERILE PACKAGING INSPECTION FOR NONCONFORMITIES - VISUAL ATTRIBUTES": FREQUENCY: EVERY 30 MINUTES SAMPLE QUANTITY: NOT LESS THAN (NLT) 3 BLISTERS PER CAVITY. ACCEPTANCE CRITERIA: ACCEPT = 0/ REJECT = 1. DEFECT RATE ANALYSIS THERE HAVE ONLY BEEN 5 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 THIS DEFECT WHICH SHOULD BE 2.50% BASED ON OUR PROCESS INSTRUCTION. IN ADDITION, ALL OF 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. TO DATE, IT WAS WELL WITHIN OUR ACCEPTED AQL LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSION: A REVIEW OF BATCH RECORDS 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. 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.
DEVICE 2 OF 5. E1: COMPLAINANT STATE: (B)(6). COMPLAINANT COUNTRY: JAPAN. NAME OF AFFILIATION: (B)(6) HOSPITAL. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. BATCH RECORD REVIEW: LOT: 3F06123 WAS MANUFACTURED 06/JUL/2023, IN BODOLAY LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINTS ENGINEER I PERFORMED A BATCH RECORD REVIEW ON 13/NOV/2025, 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): 1000854 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. THE REPORTED MALFUNCTION COULD BE GENERATED DURING THE MANUFACTURING PROCESS OF THE FINAL LINE, THEREFORE NO FURTHER BATCH RECORD REVIEW OF THE SUBASSEMBLY LOTS WAS REQUIRED. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: ONE PHOTOGRAPH ASSOCIATED WITH THIS CASE WAS RECEIVED AND IN THIS, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. HISTORICAL COMPLAINTS REVIEW: ON 13/NOV/2025, COMPLAINTS ENGINEER, I RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 3F06123 LOT FOR THE MALFUNCTION ¿PRIMARY PACK (STERILE PRODUCTS) EXHIBITS EXTERNAL CONTAMINATION (E.G. WATER MARKS, STAINS).¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 13/NOV/2025, COMPLAINTS ENGINEER, I RAN A QUERY IN DATABASE LOOKING FOR ANY IN-PROCESS NON-CONFORMANCE (NC)'S / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿PRIMARY PACK (STERILE PRODUCTS) EXHIBITS EXTERNAL CONTAMINATION (E.G. WATER MARKS, STAINS).¿ DEFECT FOR THE LOT NUMBER: 3F06123 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: TEST METHODS (TM) "STERILE PACKAGING INSPECTION FOR NONCONFORMITIES - VISUAL ATTRIBUTES": FREQUENCY: EVERY 30 MINUTES. SAMPLE QUANTITY: NOT LESS THAN 3 BLISTERS PER CAVITY. ACCEPTANCE CRITERIA: ACCEPT = 0/ REJECT = 1. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 5 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 THIS DEFECT WHICH SHOULD BE 2.50% BASED ON OUR PROCEDURE (PD). IN ADDITION, ALL OF THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE UNIT, WHICH CONFIRMS THAT THE LOT WAS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF 2.5. TO DATE, IT WAS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSION: A REVIEW OF BATCH RECORDS 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. 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.
TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE).
THE DISTRIBUTOR REPORTED THAT THE PRIMARY PACKAGE OF THE DRESSING HAD BLACK STAINS ALONG THE EDGES. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28640 | DUODERM | DRESSING,WOUND,OCCLUSIVE | NAD | CONVATEC DOMINICAN REPUBLIC INC | 187660 | 3F06123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |