DUODERM
Report
- Report Number
- 9618003-2025-03434
- Event Type
- Malfunction
- Date Received
- December 30, 2025
- Report Date
- December 12, 2025
- Manufacturer
- CONVATEC DOMINICAN REPUBLIC INC
- Product Code
- NAD
- UDI-DI
- 00768455150939
- 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 BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. BATCH RECORD REVIEW: LOT 4K07052 WAS MANUFACTURED ON 31/OCT/2024, IN DOYEN A LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 30/JAN/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) 1704769 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 DEFECT REPORTED BY THE CUSTOMER COULD OCCUR DURING THE SUB-ASSEMBLY PROCESS PERFORMED IN THE EXTRUSION, LAMINATION & CUTTING PROCESS (ELC) MANUFACTURING LINE. FOR THIS REASON, A DETAILED BATCH RECORD REVIEW WAS PERFORMED OF THE SUBASSEMBLY LOT MANUFACTURED IN THIS LINE. THE SUBASSEMBLY LOT: 4K06189, ORDER (B)(4), MATERIAL 1003412, WAS MANUFACTURED ON 10/28/2024 IN THE EXTRUSION, LAMINATION & CUTTING PROCESS (ELC) MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4K07053, ORDER (B)(4), MATERIAL 1003412, WAS MANUFACTURED ON 11/01/2024 IN THE ELC #11 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4L00820, ORDER (B)(4), MATERIAL 1003412, WAS MANUFACTURED ON 11/05/2024 IN THE ELC #11 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE DEFECT REPORTED BY THE CUSTOMER COULD OCCUR DURING THE SUB-ASSEMBLY PROCESS PERFORMED IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE. FOR THIS REASON, A DETAILED BATCH RECORD REVIEW WAS PERFORMED OF THE SUBASSEMBLY LOT MANUFACTURED IN THIS LINE. THE SUBASSEMBLY LOT: 4K04246, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 10/18/2024 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4K05255, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 10/29/2024 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4G03144, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 07/17/2024 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H01297, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 08/14/2024 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4J00555, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 09/03/2024 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H05035, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 09/03/2024 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H05034, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 09/01/2024 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H01293, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 08/07/2024 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H01296, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 08/13/2024 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H01297, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 08/14/2024 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE DEFECT REPORTED BY THE CUSTOMER COULD OCCUR DURING THE SUB-ASSEMBLY PROCESS PERFORMED IN THE AMK MIXER LARGE #3 & #2 MANUFACTURING LINE. FOR THIS REASON, A DETAILED BATCH RECORD REVIEW WAS PERFORMED OF THE SUBASSEMBLY LOT MANUFACTURED IN THIS LINE. THE SUBASSEMBLY LOT: 4K02643, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 10/10/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4K04244, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 10/18/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4K04171, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 10/31/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4G02776, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 07/12/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4G02777, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 07/15/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF(B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H05032, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 08/28/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H05259, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 09/04/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4J00554, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 09/05/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H05033, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 09/01/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H01289, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 08/11/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H01686, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 08/14/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H01687, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 08/22/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H02333, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 08/19/2024 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4G01361, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 07/09/2024 IN THE AMK MIXER LARGE #2 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H01078, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 08/07/2024 IN THE AMK MIXER LARGE #2 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE DEFECT REPORTED BY THE CUSTOMER COULD OCCUR DURING THE SUB-ASSEMBLY PROCESS PERFORMED IN THE AMK 450 MIXER 8 MANUFACTURING LINE. FOR THIS REASON, A DETAILED BATCH RECORD REVIEW WAS PERFORMED OF THE SUBASSEMBLY LOT MANUFACTURED IN THIS LINE. THE SUBASSEMBLY LOT: 4H03938, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 08/21/2024 IN THE AMK 450 MIXER 8 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H04434, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 08/23/2024 IN THE MIXER 450 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H01985, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 08/10/2024 IN THE MIXER 450 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4J01800, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 09/10/2024 IN THE MIXER 450 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4H02996, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 08/20/2024 IN THE MIXER 450 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 4J02640, ORDER (B)(4), MATERIAL 1738335, WAS MANUFACTURED ON 09/13/2024 IN THE AMK 450 MIXER 8 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EA. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 01/30/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BOM, AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. 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 30/JAN/2025, COMPLAINTS ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 4K07052 LOT FOR THE MALFUNCTION ¿DRESSING/RIBBON/GEL HANDLES INSUFFICIENT WOUND EXUDATE OR DOES NOT RETAIN ABSORBED WOUND EXUDATE¿ DEFECT AND ONE ADDITIONAL COMPLAINT WAS IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 30/JAN/2025, COMPLAINTS ENGINEER RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿DRESSING/RIBBON/GEL HANDLES INSUFFICIENT WOUND EXUDATE OR DOES NOT RETAIN ABSORBED WOUND EXUDATE¿ DEFECT FOR THE LOT NUMBER 4K07052 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: TEST METHODS (TM) "FLUID UPTAKE TEST": ¿ FREQUENCY: FIRST, MIDDLE, AND LAST MIX OF EACH LOT. ¿ SAMPLE QUANTITY: 6 SAMPLES PER MIX (18 SAMPLES). ¿ ACCEPTANCE CRITERIA: AVG. NOT LESS THAN 3900G/M2/24 HRS. DEFECT RATE ANALYSIS THERE HAVE BEEN (B)(4) 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 (B)(4)% BASED ON OUR STANDARD OPERATING PROCEDURE (SOP). 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 (B)(4). TO DATE, IT WAS WELL WITHIN OUR ACCEPTED AQL LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. HISTORICAL SUPPLIER CORRECTIVE ACTION REPORT (SCAR) REVIEW: ON 30/JAN/2025, SUPPLIER QUALITY ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE SUPPLIER CORRECTIVE ACTION REPORTS (SCARS) RELATED TO MASS MATERIALS: RUBBER BUTYL 402 (1254962), POLYISOBUTYLENE MEDIUM HARD (1003687), SIS POLYMER (1003751), TETRAKIS METHANE (1003888), ROSIN PENTAERYTHRITOL FLORAREZ 100H (1738453), GELATIN USP/NF 900KG MIX (1050904), PECTIN USP GRADE 900KG MIX (1050902) AND OIL MINERAL USP (1003700). AS RESULTS NO SCARS WERE IDENTIFIED. 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. A REVIEW OF HISTORICAL COMPLAINTS, NON-CONFORMANCE (NC) / CAPA, AND SCARS WERE PERFORMED, AND NO ADDITIONAL ISSUES WERE IDENTIFIED. THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT. AS PART OF THE PRELIMINARY INVESTIGATION, IT WAS DETERMINATE THAT THIS ISSUE IS NOT RELATED TO THE MANUFACTURING PROCESS. 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 4 OF 10 E1: COMPLAINANT STREET ADDRESS: (B)(6) COMPLAINANT COUNTRY: TAIWAN, PROVINCE OF CHINA. 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.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
THE DISTRIBUTOR REPORTED THAT THE DRESSING WAS UNABLE TO ABSORB THE EXUDATE. ALSO STATED, THAT THE END USER WAS FAMILIAR WITH THE USE OF WOUND DRESSINGS. THE PRODUCT WAS APPLIED TO A WOUND NEAR THE KNEE, AND DURING USE, IT WAS OBSERVED THAT THE DRESSING DID NOT ABSORB EXUDATE. THE CUSTOMER HAD SINCE DISCONTINUED USE OF THE PRODUCT. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1769483 | DUODERM | DRESSING,WOUND,OCCLUSIVE | NAD | CONVATEC DOMINICAN REPUBLIC INC | 187957 | 4K07052 | 00768455150939 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |