BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

    MDR report key: 8025671 · Received October 31, 2018

    Report

    Report Number
    9618003-2018-03082
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS STATED IN THE BATCH RECORDS OF BULKING LOTS MANUFACTURED ON THE EXTRUDER LAMINATING 10 MACHINE, MATERIALS WERE USED AS INDICATED IN THE BILL OF MATERIAL (BOM), A LINE CLEARANCE WAS PERFORMED AT THE START OF MANUFACTURING OPERATION AND AT THE END OF THE PROCESS; FURTHERMORE, PERIODIC REVIEWS OF LINE CLEARANCE REQUIREMENTS ARE PERFORMED AT THE START-UP OF EACH SHIFT AND AFTER ELECTRICAL OR MAJOR MECHANICAL ADJUSTMENTS. ON (B)(6)2018 , AN EXTRAORDINARY MAINTENANCE WAS PERFORMED TO THE EXTRUDER LAMINATING 10 MACHINE, WHILE RUNNING THE LOT NUMBER 8C04850 (ITEM 1003413) BY THE MAINTENANCE AREA, RELATED TO ¿FAILURE IN THE COOLING TOWER¿. HOWEVER, THIS FAILURE DOES NOT IMPACT THE PROPERTIES OF THE PRODUCTS BASED ON QUALITY TESTING RESULTS. THE ADHESIVES TEST AND THE ¿STRIP TO STRIP T-PEEL WAS PERFORMED FOR THE FIRST PIECE OR AFTER MACHINE STOP WITH SATISFACTORY RESULTS. THE REQUIRED VISUAL INSPECTION TESTING WAS PERFORMED PER HOURS. DIMENSIONS AND PRODUCT CHARACTERISTICS TESTING WERE PERFORMED EVERY HALF HOUR; THE OVERALL THICKNESS WAS FOUND IN RANGE. ALL QUALITY AND MANUFACTURING TESTING WERE CONSIDERED ACCEPTABLE AND PROCESS PARAMETERS WERE PROPERLY SET AS DOCUMENTED. FINALLY, INSPECTIONS ARE PERFORMED BY QUALITY TO THE PACKAGED PRODUCT AND ALL RESULTS WERE SATISFACTORY. ON (B)(6)2019 , A QUERY WAS PERFORMED TO EACH INDIVIDUAL IMPACTED LOT (FINAL AND BULKING LOTS) IN THE SYSTEM TO CONFIRM IF ANY LOCAL EVENT, SUCH AS REWORK OR NONCONFORMANCE OCCURRED DURING THE MANUFACTURING PROCESS OF THOSE LOTS REGARDING TO THE SAME FAILURE MODE REPORTED. AS RESULT, NOT EVENTS WERE FOUND RELATED TO THIS FAILURE MODE. ON (B)(6)2019 , A QUERY WAS RUN FROM JANUARY 01, 2019 TO DECEMBER 31, 2018 TO COVER THE FULL YEAR IN THE SYSTEM LOOKING FOR CUSTOMERS REPORTING COMPLAINTS, ASSOCIATED TO THE REPORTED MALFUNCTION IN THE DOYEN A MACHINE. AS RESULT, A TOTAL OF SIX (06) COMPLAINTS WERE FOUND ASSOCIATED TO THE MENTIONED FAILURE MODE (INCLUDING THE ONES TRIGGERING THIS NONCONFORMANCE). NO NEGATIVE TREND IS OBSERVED, BASED ON THE TOTAL QUANTITY MANUFACTURED OF IMPACTED FINAL LOTS. BASED ON THE INITIAL ASSESSMENT PERFORMED THROUGH REVISION OF THE BATCH RECORDS DOCUMENTATION, PICTURES PROVIDED BY CUSTOMERS IN COMPLAINTS REPORTED AND PROCESS EVALUATION, THIS EVENT COULD NOT BE CONFIRMED DUE TO SAMPLES WERE NOT AVAILABLE TO MEASURE DRESSING DIMENSIONS, COULD NOT BE CONFIRMED IF PRODUCTS WERE USED DURING THE RECOMMENDED PERIOD AS ESTABLISHED IN THE INSTRUCTION FOR USE. RECOMMENDED MEDICAL INSTRUCTIONS WERE PROPERLY FOLLOWED FOR THE PRODUCT 8C05035. NO LOCAL EVENTS WERE FOUND RELATED TO MANUFACTURING REQUIREMENTS AS PER BATCH RECORDS REVIEW OF BULKING AND FINAL LOTS. HOWEVER, A DEFECT NOTIFICATION WAS GIVEN TO QUALITY AND MANUFACTURING ASSIGNED TO THE EXTRUDER LAMINATING 10 MACHINE TO MAKE THEM AWARE OF COMPLAINTS REPORTED BY CUSTOMERS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTING SITE: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED CONFIRMING THAT THE PRODUCT WAS USED FOR FOURTEEN (14) DAYS, AND NOT TEN (10) DAYS THAT WAS INITIALLY REPORTED.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME ¿ DRESSING, WOUND, OCCLUSIVE. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PER THE INFORMATION FOR USE (IFU), THE MAXIMUM RECOMMENDED WEAR TIME FOR THIS PRODUCT IS UP TO SEVEN (7) DAYS. 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 AFTER APPLICATION ONCE ON PATIENT, THE DRESSING IS DIFFICULT TO REMOVE FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE PRODUCT WAS USED FOR TEN (10) DAYS. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866618 DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING NAD CONVATEC DOMINICAN REPUBLIC INC 187959 8C05035

    Patients

    Seq Age Sex Outcome Treatment
    1