BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUR-FIT NATURA

    MDR report key: 23567124 · Received November 17, 2025

    Report

    Report Number
    9618003-2025-02893
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Report Date
    October 22, 2025
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 12 OF 20. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE ARE PHOTOGRAPHS ASSOCIATED WITH THIS CASE. PHOTOS AND SAMPLES WERE REQUESTED BUT ARE NOT AVAILABLE FOR THIS COMPLAINT. BATCH RECORD REVISION RESULTS: LOT 5A05209 WAS MANUFACTURED ON 23/JAN/2025, IN FFS #1 LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 31/OCT/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) 1715173 AND MANUFACTURING ORDER 1767819. 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 ACCORDION ASSEMBLY LINE. FOR THIS REASON, A DETAILED BATCH RECORDS REVIEW WAS PERFORMED OF THE SUBASSEMBLY LOTS MANUFACTURED IN THIS LINE. THE SUBASSEMBLY LOT 5A00646, ORDER 1802342, MATERIAL 1714356, WAS MANUFACTURED ON 23/JAN/2025 IN THE ACCORDION ASSEMBLY LINE, WITH A TOTAL OF (B)(4) EACHES. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 31/OCT/2025 AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE COMPONENTS FOR ASSEMBLY WERE CORRECT AS PER BILL OF MATERIALS (BOM) AND THE EQUIPMENT SETTINGS WERE THE APPLICABLE ONES. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. THE SUBASSEMBLY LOT 4M00556, ORDER 1802415, MATERIAL 1714356, WAS MANUFACTURED ON 11/DEC/2024 IN THE ACCORDION ASSEMBLY LINE, WITH A TOTAL OF (B)(4) EACHES. THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 31/OCT/2025 AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE COMPONENTS FOR ASSEMBLY WERE CORRECT AS PER BILL OF MATERIALS (BOM) AND THE EQUIPMENT SETTINGS WERE THE APPLICABLE ONES. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. HISTORICAL COMPLAINTS REVIEW: ON 31/OCT/2025, COMPLAINTS ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 5A05209 LOT FOR THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (MOLDABLE ONLY)¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 31/OCT/2025, COMPLAINT ENGINEER 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 5A05209 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 ACCORDION ASSEMBLY LINE, TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS. TEST METHODS (TM) ¿VISUAL NONCONFORMITIES - LAMINATED ADHESIVE PRODUCTS¿. FREQUENCY: HOURLY, SAMPLE QUANTITY: (B)(4) SAMPLES, ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. DIMENSIONAL TEST: FREQUENCY: TWICE PER SHIFT (APPROX. EVERY 4 HOURS), SAMPLE QUANTITY: (B)(4) SAMPLES, ACCEPTANCE CRITERIA: ACCEPT = 1 / REJECT = 2. 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 0.208% WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR LEAKAGE, WHICH SHOULD BE 0.25% 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 IS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF 0.25. IMPORTANTLY, TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: THE BATCH RECORDS HAVE BEEN REVIEWED, AND ALL NECESSARY TESTS DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAVE BEEN COMPLETED AND MET THE REQUIREMENTS. IT'S IMPORTANT TO NOTE THAT THE FAILURE RATE IS WELL WITHIN OUR ACCEPTED AQL LEVEL FOR THIS TYPE OF DEFECT. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    IT WAS REPORTED BY DISTRIBUTOR THAT THE CONSUMER REPORTED ABOUT THE MOLDABLE STARTER HOLE WAS OFF-CENTER, WHICH RESULTED IN REDUCED WEAR TIME AND LEAKAGE. THE CONSUMER, A LONG-TIME USER OF THE PRODUCT, TYPICALLY EXPERIENCED A WEAR TIME OF TWO TO THREE DAYS. HOWEVER, WITH THE RECENT TWO MARKET UNITS RECEIVED, SHE NOTED THAT THE STARTER HOLE WAS WAY OFF CENTER. DESPITE THE DEFECT, SHE USED THE PRODUCTS AS THEY WERE THE ONLY ONES AVAILABLE TO HER. SHE OBSERVED THAT HER WEAR TIME WAS SIGNIFICANTLY REDUCED TO JUST ONE DAY AND EXPERIENCED LEAKAGE DUE TO THE IRREGULARITY OF THE MOLDABLE SEAL. THE PHOTOGRAPHS DEPICTING THE ISSUE HAVE ALSO BEEN RECEIVED FROM THE COMPLAINANT. A TOTAL OF TWO MARKET UNITS (TWENTY UNITS) WERE AFFECTED. A THIRD MARKET UNIT FROM THE SAME LOT REMAINED UNOPENED AT HOME AND HAD NOT YET BEEN ASSESSED FOR DEFECTS. WHEN ASKED ABOUT SKIN IMPACTS, THE CONSUMER DENIED HARM BUT CONFIRMED MILD SKIN IRRITATION AND REDNESS DUE TO FREQUENT CHANGES AND LEAKAGE. THE CONSUMER DID NOT SEEK MEDICAL EVALUATION. SHE MENTIONED THAT THE FREQUENT CHANGES LED TO MORE ADHESIVE RESIDUE, WHICH SHE HAD TO CLEAN USING HER REMOVER WIPES. SHE DENIED ANY BLEEDING OR INJURY, DESCRIBING THE ISSUE AS IRRITATION. SHE WAS INSTRUCTED AGAIN ON CRUSTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2873759 SUR-FIT NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 421034 5A05209

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female PROTECTIVE POWDER.| SEALS.| STING-FREE ADHESIVE REMOVER WIPE.| STING-FREE SKIN BARRIER WIPE.