SUR-FIT NATURA
Report
- Report Number
- 9618003-2025-02718
- Event Type
- Malfunction
- Date Received
- September 22, 2025
- Report Date
- August 28, 2025
- Manufacturer
- CONVATEC DOMINICAN REPUBLIC INC
- Product Code
- EXE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
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: PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPH ASSOCIATED WITH THIS CASE WAS RECEIVED. NO RETURN SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT. BATCH RECORD REVISION RESULTS: PACKAGING PROCESS PERFORMED IN THE ATS #2 LINE: LOT 4A00644 WAS MANUFACTURED ON 03/JAN/2024, IN ATS #2 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 26/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) 1703895 AND MANUFACTURING ORDER (B)(4). THE PRODUCTION PROCESS, IN-PROCESS CONTROL, TESTING RESULTS, AND PACKAGING OF PRODUCTS WERE RUN ACCORDING TO THE PROCESS INSTRUCTION (PI). TRILAMINATION PROCESS PERFORMED IN THE DELTA CRUSADER LINE: THE SUBASSEMBLY 4A01269, ORDER (B)(4), MATERIAL 1220483 WAS MANUFACTURED ON 05/JAN/2024 IN THE DELTA CRUSADER LINE. THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 26/NOV/2025, 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 (PI). EXTRUSION, LAMINATION AND CUTTING PROCESS (ELC) PERFORMED IN THE ELC #6 LINE: THE SUBASSEMBLY 3L01281, ORDER (B)(4), MATERIAL 1220482 WAS MANUFACTURED ON 22/NOV/2023 IN THE ELC #6 LINE. THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 26/NOV/2025, 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 (PI). THE SUBASSEMBLY 3L05495, ORDER (B)(4), MATERIAL 1220482 WAS MANUFACTURED ON 02/DEC/2023 IN THE ELC #6 LINE. THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 26/NOV/2025, 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 (PI). THE SUBASSEMBLY 4A00045, ORDER (B)(4), MATERIAL 1220482 WAS MANUFACTURED ON 05/JAN/2024 IN THE ELC #6 LINE. THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 26/NOV/2025, 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 (PI). MIXING PROCESS PERFORMED IN THE AMK MIXER LARGE #2, APV MIXER, AND MIXER 315 MANUFACTURING LINE: THE SUBASSEMBLY 3K04892, ORDER (B)(4), MATERIAL 1002206 WAS MANUFACTURED ON 31/OCT/2023 IN THE APV MIXER LINE. THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 26/NOV/2025, 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 (PI). THE SUBASSEMBLY 3L01631, ORDER (B)(4) MATERIAL 1002206 WAS MANUFACTURED ON 10/NOV/2023 IN THE APV MIXER LINE. THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 26/NOV/2025, 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 (PI). THE SUBASSEMBLY 3L02140, ORDER (B)(4), MATERIAL 1002205 WAS MANUFACTURED ON 28/NOV/2023 IN THE MIXER 315 LINE. THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 26/NOV/2025, 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 (PI). THE SUBASSEMBLY 3L04215, ORDER (B)(4), MATERIAL 1002205 WAS MANUFACTURED ON 01/DEC/2023 IN THE MIXER 315 LINE. THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 26/NOV/2025, 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 (PI). THE SUBASSEMBLY 4A00048, ORDER (B)(4), MATERIAL 1002206 WAS MANUFACTURED ON 04/JAN/2024 IN THE AMK MIXER LARGE #2 LINE. THE COMPLAINTS ENGINEER PERFORMED A BATCH RECORD REVIEW ON 26/NOV/2025, 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 (PI). MASS SUBLOTS REVISION RESULTS: THE QUALITY INSPECTION OF THE MASS SUBLOTS WAS CONDUCTED FOR THE FOLLOWING ERP MATERIALS AND THEIR RESPECTIVE LOTS: ERP MATERIAL 1003687 (POLYISOBUTYLENE MEDIUM HARD): PC3C20-1, PC3C22-1, PC3C24-1, AND PC3C25-1. ERP MATERIAL 1050902 (PECTIN USP GRADE 900KG MIX): SK30042255, SK30042392, SK30042987. ERP MATERIAL 1050903 (SODIUM CMC FCC-GRADE 900KG MIX): 80183, 80217, 80212, 80223, 80130, C230988. ERP MATERIAL 1050904 (GELATIN USP/NF 900KG MIX): OT230-5, OT230-4, OT230-6, OT230-3, OT219-1, OT219-3, OT322-2, OT322-3, OT127-1A, OT328-4. ALL THE INSPECTION RESULTS WERE ACCEPTABLE, WITH NO ISSUES IDENTIFIED. HISTORICAL COMPLAINTS REVIEW: ON 26/NOV/2025, THE COMPLAINTS ENGINEER RAN A QUERY IN DATABASE TO VERIFY THE COMPLAINTS REPORTED FOR THE LOT 4A00644 AND THE MALFUNCTION ¿SKIN BARRIER DOES NOT MOLD AROUND STOMA (E.G TOO STIFF, TOO DRY, TEARS /CRUMBLES WHEN MOLDING) AT POINT OF APPLICATION¿ AND AS RESULT ANY ADDITIONAL COMPLAINT WAS IDENTIFIED DURING THIS SEARCH AS PER WORK INSTRUCTIONS (WI). HISTORICAL NONCONFORMANCE REVIEW: ON 26/NOV/2025, THE COMPLAINTS ENGINEER RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿SKIN BARRIER DOES NOT MOLD AROUND STOMA (E.G TOO STIFF, TOO DRY, TEARS /CRUMBLES WHEN MOLDING) AT POINT OF APPLICATION¿ FOR LOTS NUMBER 4A00644, 4A01269, 3L01281, 3L05495, 4A00045, 3K04892, 3L01631, 3L02140, 3L04215, AND 4A00048. AS A RESULT, NO NONCONFORMANCE / CAPA (S) FOR THIS MALFUNCTION WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOTS. CONCLUSION: NO PHOTOGRAPHS FOR THIS COMPLAINT ISSUE. THEREFORE, IT WAS NOT POSSIBLE TO INVESTIGATE THE REPORTED ISSUE. A BATCH RECORD REVIEW WAS CONDUCTED FOR THE FINAL PRODUCT LOT 4A00644, INCLUDING THE BULK LOTS (4A01269, 3L01281, 3L05495, 4A00045, 3K04892, 3L01631, 3L02140, 3L04215, AND 4A00048), CONFIRMING THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE WERE COMPLETED AND MET THE NECESSARY STANDARDS. NO DISCREPANCIES OR CAPAS RELATED TO THIS ISSUE WERE IDENTIFIED IN THE DOCUMENTATION AND EQUIPMENT USED DURING TESTING WAS WITHIN CALIBRATION, ENSURING THE RELIABILITY OF THE RESULTS. THE ANNUAL TESTING REVIEW OF THE CHEMICALS USED ALSO SHOWED ACCEPTABLE RESULTS, INDICATING THAT THERE ARE NO ISSUES RELATED TO THE RAW MATERIALS OR MANUFACTURING PROCESSES. NO SUPPLIER CHANGES WERE IDENTIFIED. 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 5 OF 20. E1: COMPLAINANT STREET ADDRESS: (B)(6). COMPLAINANT COUNTRY: CANADA. 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 END USER REPORTED THAT COMPANY'S KNOWN TWENTY MOLDABLE WAFERS FROM TWO MARKET UNITS WERE NOT EASY TO MOLD. MOREOVER, THE END USER MENTIONED THAT THE APPLIANCES NOW ONLY LASTED FOR TEN-TWELVE HOURS COMPARED TO HIS USUAL THREE-FIVE DAYS. THERE WAS NO HARM REPORTED. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2069801 | SUR-FIT NATURA | PROTECTOR, OSTOMY | EXE | CONVATEC DOMINICAN REPUBLIC INC | 413423 | 4A00644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |