DUODERM
Report
- Report Number
- 9618003-2026-00030
- Event Type
- Malfunction
- Date Received
- January 6, 2026
- Report Date
- December 12, 2025
- Manufacturer
- CONVATEC DOMINICAN REPUBLIC INC
- Product Code
- NAD
- UDI-DI
- 00768455150922
- 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. BATCH RECORD REVIEW: LOT 3D01263 WAS MANUFACTURED ON 22/APR/2023, IN BODOLAY LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/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) 1704768 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 WAS 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: 3D02629, ORDER (B)(4), MATERIAL 1003411, WAS MANUFACTURED ON 19/APR/2023 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 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3D00369, ORDER (B)(4), MATERIAL 1003411, WAS MANUFACTURED ON 14/APR/2023 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 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (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: 3C06202, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 05/APR/2023 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3D00828, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 18/APR/2023 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3C06191, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 03/APR/2023 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3D01649, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 20/APR/2023 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3D02631, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 22/APR/2023 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3D02630, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 21/APR/2023 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3C06980, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 04/APR/2023 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3D00827, ORDER (B)(4), MATERIAL 1725587, WAS MANUFACTURED ON 15/APR/2023 IN THE ROPING DURAHESIVE MIX MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (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 #2 & #3 MANUFACTURING LINE. FOR THIS REASON, A DETAILED BATCH RECORD REVIEW WAS PERFORMED OF THE SUBASSEMBLY LOT MANUFACTURED IN THIS LINE. THE SUBASSEMBLY LOT: 3C06976, ORDER (B)(4), MATERIAL 1002207, WAS MANUFACTURED ON 04/APR/2023 IN THE AMK MIXER LARGE #2 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3C06687, ORDER (B)(4), MATERIAL 1002207, WAS MANUFACTURED ON 30/MAR/2023 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3C06977, ORDER (B)(4), MATERIAL 1002207, WAS MANUFACTURED ON 10/APR/2023 IN THE AMK MIXER LARGE #2 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3D01645, ORDER (B)(4), MATERIAL 1002207, WAS MANUFACTURED ON 16/APR/2023 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3D01646, ORDER (B)(4), MATERIAL 1002207, WAS MANUFACTURED ON 19/APR/2023 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3C05532, ORDER (B)(4), MATERIAL 1002207, WAS MANUFACTURED ON 26/MAR/2023 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3C06686, ORDER (B)(4), MATERIAL 1002207, WAS MANUFACTURED ON 31/MAR/2023 IN THE AMK MIXER LARGE #2 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3D02998, ORDER (B)(4), MATERIAL 1002207, WAS MANUFACTURED ON 23/APR/2023 IN THE AMK MIXER LARGE #2 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3D01647, ORDER (B)(4), MATERIAL 1002207, WAS MANUFACTURED ON 23/APR/2023 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3D02997, ORDER (B)(4), MATERIAL 1002207, WAS MANUFACTURED ON 21/APR/2023 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 3C06979, ORDER (B)(4), MATERIAL 1002207, WAS MANUFACTURED ON 03/APR/2023 IN THE AMK MIXER LARGE #3 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 23/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: A PHOTOGRAPH ASSOCIATED WITH THIS CASE WAS RECEIVED; HOWEVER, THE REPORTED DEFECT CANNOT BE APPRECIATED. NO UNUSED RETURN SAMPLE WAS EXPECTED. HISTORICAL COMPLAINTS REVIEW: ON 23/FEB/2026, COMPLAINTS ENGINEER RAN A QUERY IN DATABASE TO VERIFY THE COMPLAINTS REPORTED FOR THE 3D01263 LOT FOR THE MALFUNCTION ¿DRESSING/RIBBON/GEL HANDLES INSUFFICIENT WOUND EXUDATE OR DOES NOT RETAIN ABSORBED WOUND EXUDATE¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 23/FEB/2026, 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 3D01263 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE AND 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) "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 HAS BEEN 1 DEFECTIVE PART CONFIRMED TO DATE FROM A LOT SIZE OF (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF (B)(4), WHICH IS 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 IS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF (B)(4). TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. HISTORICAL SCARS REVIEW: ON 23/FEB/2026, SUPPLIER QUALITY ENGINEER RAN A QUERY IN TRACKWISE IN ORDER TO VERIFY THE SCARS RELATED TO MASS MATERIALS: RUBBER BUTYL 402 (1254962), POLYISOBUTYLENE MEDIUM HARD (1003687), SIS POLYMER (1003751), TETRAKIS METHANE (1003888), PENTAERYTHRITOL ESTER OF ROSIN (1003749), SODIUM CMC FCC-GRADE 900KG MIX (1050903), GELATIN USP/NF 900KG MIX (1050904), PECTIN USP GRADE 900KG MIX (1050902) AND OIL MINERAL USP (1003700). AS RESULTS NO SUPPLIER CORRECTIVE ACTION REPORT (SCAR) 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) / CORRECTIVE AND PREVENTIVE ACTIONS (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.
E1: (B)(6). 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 MENTIONED THAT THE CUSTOMER REPORTED DRESSING DID NOT ABSORB THE EXUDATE. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 599938 | DUODERM | DRESSING,WOUND,OCCLUSIVE | NAD | CONVATEC DOMINICAN REPUBLIC INC | 187955 | 3D01263 | 00768455150922 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |