BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

    MDR report key: 8157663 · Received December 12, 2018

    Report

    Report Number
    9618003-2018-04042
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D4: UNIQUE IDENTIFIER (UDI) H6: INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS. AN INVESTIGATION WAS COMPLETED FOR THIS COMPLAINT BY THE ASSIGNED MANUFACTURING SITE INVESTIGATION TEAM. THE COMPLAINT SUMMARY OF THIS INVESTIGATION REQUIRED REWORK. A CORRECTIVE ACTIONS/PREVENTIVE ACTIONS (CAPA) WAS RAISED, AND AN UPDATED/CORRECTED INVESTIGATION SUMMARY HAS BEEN COMPLETED IN ACCORDANCE WITH ASSIGNED CAPA. A SUPPLEMENTAL MDR IS BEING SUBMITTED TO DOCUMENT THE COMPLETION OF INVESTIGATION REWORK AND FINAL INVESTIGATION; THE COMPLAINT RECORD WILL PROCEED TO CLOSURE. BATCH RECORD REVIEW: LOT 8A06770 WAS MANUFACTURED ON 02/02/2018, IN BODOLAY LINE, WITH A TOTAL OF (B)(4) EA. COMPLIANCE ENGINEER PERFORMED A BATCH RECORD REVIEW ON 09/30/2020, 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 ID 1713148 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE IS A PHOTOGRAPH ASSOCIATED WITH THIS CASE AND IN IT, THE DEFECT REPORTED BY THE CUSTOMER CAN BE SEEN. NO UNUSED RETURN SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED ON THE RESULTS OF THE PRELIMINARY INVESTIGATION, THE BATCH RECORD REVIEWS WERE PERFORMED, AND NO DISCREPANCIES WERE FOUND. NO HARM WAS REPORTED FROM ANY OF THE COMPLAINANTS. A REVISION OF THE IMPROVEMENTS MADE TO THE PROCESS WAS PERFORMED, AND ACTIONS HAVE BEEN IMPLEMENTED FOR SOME OF THE DEFECT TYPES REPORTED. IN ADDITION, A RETRAINING IN THE TM-002 WILL BE GIVEN TO THE QUALITY PERSONNEL OF THE BODOLAY LINE, IN ORDER TO REINFORCE THE CORRECT EXECUTION OF THE METHOD 7, WHICH INDICATES THE OUTLINES THAT THE VISUAL TESTING REQUIRED TO ENSURE THAT THE PRIMARY PACKAGING, SECONDARY PACKAGING AND PACKAGE PRINTING ARE FREE FROM NONCONFORMITIES BY VISUAL MEANS. FURTHERMORE, AN NCR SEARCH CONDUCTED SHOWS THAT NO ADVERSE TREND WAS IDENTIFIED FROM JANUARY 2018 TO AUGUST 2020 FOR THIS FAILURE MODE. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT 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.

    Additional Manufacturer Narrative · 1

    (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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FOREIGN MATTER WAS PRESENT IN THE SEALING PART OF THE PEEL POUCH IN 45 DRESSINGS. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995155 DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING NOT APPLICABLE NAD CONVATEC DOMINICAN REPUBLIC INC 412002 8A06770

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown