BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 24017325 · Received January 9, 2026

    Report

    Report Number
    9618003-2026-00258
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Report Date
    December 16, 2025
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. CURRENT QUALITY CONTROLS DURING THE MANUFACTURING PROCESS: SINCE THE COMPLAINT DID NOT INCLUDE A SPECIFIC LOT NUMBER, THE INVESTIGATION USED THE PART NUMBER AND PRODUCT DESCRIPTION PROVIDED TO IDENTIFY THE CORRESPONDING MANUFACTURING LINE, THE RELEVANT PRODUCT: NATURA WFR D/HESIVE MLD 33/57MM 1X10 EUR. BASED ON THIS INFORMATION, PROCESS INSTRUCTION (PI), CORRESPONDING TO THE ATS #2, WAS IDENTIFIED. THE ASSOCIATED IN PROCESS CONTROLS WERE REVIEWED TO CONFIRM THAT THE CONTROLS ESTABLISHED FOR THIS MANUFACTURING LINE ARE ADEQUATE TO DETECT AND PREVENT THE REPORTED FAILURE MODE. TEST METHODS (TM) "FABRIC COLLAR TO FLANGE WELD ATTACHMENT STRENGTH" - METHOD 2: (B)(4). TEST METHODS (TM) "FLANGE WELD INTEGRITY - ADHESIVE WAFERS" - METHODS 12 AND 13: (B)(4). IN ADDITION TO THE IN-PROCESS CHECKS PERFORMED ON THE ATS #2 LINE, THE MATERIAL USED TO FORM THE WAFER GOES THROUGH A PREVIOUS STEP IN THE EXTRUSION, LAMINATION & CUTTING (ELC) PROCESS ON THE ELC #6 LINE. ACCORDING TO PROCESS INSTRUCTION (PI) THIS STEP INCLUDES A TENSILE TEST TO CONFIRM THAT THE LAMINATED MATERIAL HAS THE PROPER STRENGTH BEFORE IT MOVES TO THE DOWNSTREAM MOLDING PROCESS. THIS CONTROL HELPS IDENTIFY ANY MATERIAL ISSUES THAT COULD CONTRIBUTE TO THE ¿WAFER DIFFICULT TO MOLD¿ CONDITION. TEST METHODS (TM) " TENSILE TESTING": (B)(4). RISK MANAGEMENT: ALL INSPECTIONS AND CONTROLS ARE DOCUMENTED IN ANALYSES FOR THE DEVICE SPECIFICATION. THE SEVERITY OF POTENTIAL FAILURE MODES WAS RATED AS 3 (MODERATE), AND THE OCCURRENCE WAS 1 (REMOTE). ACCORDING TO RISK MANAGEMENT PROCEDURE, THE LIKELIHOOD OF HARM TO THE END USER WAS CONSIDERED HIGHLY UNLIKELY DUE TO THE EFFECTIVENESS OF THE CONTROLS IN PLACE. TREND ANALYSIS: AS PART OF THE INVESTIGATION, A REVIEW WAS CONDUCTED ON COMPLAINTS ASSOCIATED WITH THE MALFUNCTION ¿SKIN BARRIER DOES NOT MOLD AROUND STOMA (E.G. TOO STIFF, TOO DRY, TEARS/CRUMBLES WHEN MOLDING)¿ FOR PRODUCTS MANUFACTURED ON ATS #2 PRODUCTION LINE. THE ANALYSIS COVERED DATA FROM 2024 TO 2026. FOUR (4) ADDITIONAL COMPLAINTS WERE FOUND DURING THE REVIEW; HOWEVER, THE FREQUENCY OBSERVED DOES NOT REPRESENT A TREND. THE ASSOCIATED INVESTIGATIONS DID NOT IDENTIFY ANY MANUFACTURING ISSUES, PROCESS DEVIATIONS, OR MATERIAL RELATED FACTORS THAT COULD EXPLAIN THE REPORTED BEHAVIOR. BASED ON THE INFORMATION AVAILABLE, THE MALFUNCTION CANNOT BE ATTRIBUTED TO A SYSTEMIC ISSUE RELATED TO THE POUCH OR THE PRODUCTION LINE, AND THEREFORE, NO TREND WAS OBSERVED. PERSONNEL NOTIFICATION AND TRAINING: AS PART OF THE INVESTIGATION, THE TEAMS INVOLVED IN THE MANUFACTURING OF THE AFFECTED PRODUCT WERE INFORMED ABOUT THE REPORTED ISSUE. THE GOAL WAS TO RAISE AWARENESS AND REINFORCE THE IMPORTANCE OF INSPECTION PROTOCOLS, ESPECIALLY CONSIDERING THAT NO SPECIFIC LOT NUMBER WAS AVAILABLE. THE NOTIFICATION SESSIONS SERVED AS A REMINDER TO REMAIN VIGILANT AND MAINTAIN HIGH STANDARDS IN DAILY OPERATIONS. THIS EFFORT HELPED ENSURE THAT EVERYONE INVOLVED CONTINUES TO FOLLOW ESTABLISHED CONTROLS AND REMAINS ATTENTIVE TO ANY SIGNS OF DEVIATION, EVEN IN CASES WHERE PRODUCT TRACEABILITY WAS LIMITED. FOR FURTHER DETAILS, REFER TO THE TAB ¿REFERENCE INFO / COMMENTS¿ IN THE COMPLAINT INVESTIGATION RECORD. CONCLUSION: BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION COULD NOT IDENTIFY THE SPECIFIC LOT NUMBER ASSOCIATED WITH THE REPORTED EVENT, WHICH LIMITED THE ABILITY TO PERFORM A TARGETED REVIEW OF MANUFACTURING RECORDS. HOWEVER, ALL APPLICABLE IN PROCESS CONTROLS, UPSTREAM MATERIAL EVALUATIONS, AND QUALITY INSPECTIONS FOR ATS #2 AND THE RELATED ELC #6 PROCESSES WERE ASSESSED AND FOUND TO BE OPERATING AS INTENDED. NO PROCESS DEVIATIONS, MATERIAL ISSUES, OR MANUFACTURING ABNORMALITIES WERE IDENTIFIED THAT COULD CONTRIBUTE TO THE REPORTED FAILURE MODE. A TREND ANALYSIS OF COMPLAINTS ASSOCIATED WITH MALFUNCTION FOR PRODUCTS MANUFACTURED ON ATS #2 BETWEEN 2024 AND 2026 IDENTIFIED FOUR (4) ADDITIONAL COMPLAINTS; HOWEVER, THESE DO NOT CONSTITUTE A TREND. THE AVAILABLE EVIDENCE DOES NOT INDICATE A SYSTEMIC ISSUE WITHIN THE MANUFACTURING PROCESS OR PRODUCT DESIGN. FURTHERMORE, NO HARMS WERE REPORTED IN ASSOCIATION WITH THIS COMPLAINT. INVESTIGATION OUTCOME: NO SYSTEMIC ISSUE WAS DETECTED. THE COMPLAINT APPEARS TO BE AN ISOLATED CASE WITH NO EVIDENCE OF RECURRING PRODUCT FAILURE. BASED ON THE AVAILABLE DATA AND CONTROLS IN PLACE, THE INVESTIGATION OUTCOME WAS INCONCLUSIVE, WITH A LOW RISK OF RECURRENCE. 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.

    Additional Manufacturer Narrative · 0

    DEVICE 3 OF 5. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED DECREASED ADHESION OF THE MASS, AFFECTING FIVE UNITS OUT OF THE MARKET. SHE STATED THAT HER WEAR TIME HAD DECREASED FROM THREE TO FOUR DAYS TO REQUIRING TWICE DAILY OR DAILY CHANGES AFTER STARTING A NEW BOX OF SKIN BARRIERS. SHE NOTED THAT THE MOLDABLE SECTION FELT LESS PLIABLE WHEN SHE ATTEMPTED TO MOLD IT TO FIT HER STOMA AND ALSO REPORTED THAT THE MASS FELT LESS ADHESIVE COMPARED TO PRIOR SKIN BARRIERS. THE CONSUMER HAD DISCARDED THE PACKAGING AND WAS UNABLE TO PROVIDE THE LOT NUMBER. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331125 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411804

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female