BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 21215764 · Received January 23, 2025

    Report

    Report Number
    9618003-2025-00371
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Report Date
    December 30, 2024
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455125180
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: B5: DESCRIBE EVENT OF PROBLEM - IN THE INITIAL EMDR, IT WAS MENTIONED THAT "NO PHOTO WAS AVAILABLE AT THIS TIME". HOWEVER, PHOTOS WERE RECEIVED LATER AND INVESTIGATION WAS CARRIED OUT. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. 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. BATCH RECORD REVISION RESULTS: LOT 3J04516 WAS MANUFACTURED ON 28/SEP/2023, IN MLK-3 LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 29/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)1051279 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. HISTORICAL COMPLAINTS REVIEW: ON 29/JAN/2025, COMPLAINTS INVESTIGATOR RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 3J04516 LOT FOR THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (PRE-CUT ONLY)¿ DEFECT AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. HISTORICAL NONCONFORMANCE REVIEW: ON 29/JAN/2025, COMPLAINTS INVESTIGATOR 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 (PRE-CUT ONLY)¿ DEFECT FOR THE LOT NUMBER 3J04516 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) -001 "FLANGE WELD INTEGRITY - ADHESIVE WAFERS"- METHOD 13: FREQUENCY: HOURLY SAMPLE QUANTITY: 6 SAMPLES PER ROTARY ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 5 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE OF (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4) WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR LEAKAGE WHICH SHOULD BE (B)(4) BASED ON OUR PROCESS INSTRUCTION (PI). 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 (B)(4). IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL)FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: NO PHOTOGRAPHS FOR THIS COMPLAINT ISSUE. THEREFORE, IT WAS NOT POSSIBLE TO CONDUCT AN INVESTIGATION FOR THE REPORTED ISSUE. 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. 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 1 OF 5. 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.

    Description of Event or Problem · 0

    TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE).

    Description of Event or Problem · 0

    THE CONSUMER REPORTED THAT FIVE WAFERS FROM ONE MARKET UNIT (MU) HAD OFF CENTERED STARTER HOLE ISSUE. THE CONSUMER ALSO STATED THAT THE OFF CENTERED HOLES WERE IN VARYING DEGREES LIKE SOME WERE MILD AND SOME WERE MORE SEVERE. THE END USER ALSO REPORTED THAT SHE WAS ABLE TO WEAR SOME OF THE AFFECTED WAFERS, BUT WEAR TIME DECLINED FROM TWO DAYS TO LESS THAN ONE DAY. SHE STATED THAT ONE OF THE AFFECTED WAFERS WERE SO BAD THAT SHE WAS UNABLE TO ATTACH IT TO THE COMPANY¿S KNOWN POUCH. ALSO, MENTIONED THAT ONE DAY SHE HAD TO CHANGE THE PRODUCT THREE TIMES DUE TO THE OFF CENTERED HOLES. SHE STATED THAT EMOTIONALLY SHE WAS VERY UPSET AND HAD LOST FAITH IN THE PRODUCT. THE PRODUCT WAS USED BY PATIENT. NO PHOTO WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931416 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 125271 3J04516 00768455125180

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female