BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

    MDR report key: 7753707 · Received August 6, 2018

    Report

    Report Number
    9618003-2018-00828
    Event Type
    Malfunction
    Date Received
    August 6, 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

    THIS COMPLAINT HAS BEEN EVALUATED. THERE IS A PHOTOGRAPH ASSOCIATED WITH THIS CASE RECEIVED FROM CUSTOMER, THERE ARE NO RETURNED SAMPLE TO PERFORMED PHYSICAL TESTING; HOWEVER A ROOT CAUSE INVESTIGATION HAS BEEN RAISED TO INVESTIGATE THIS ISSUE. A BATCH RECORD REVIEW WAS PERFORMED ON OCTOBER 02, 2018, FOR LOT NUMBER: 8C01105, SAP MATERIAL: 1000915, ICC CODE 187955, PRODUCT DESCRIPTION: DUOACTIVE XTHIN DRS 10X10CM (1X10PK) JP. THIS PRODUCT WAS MANUFACTURED ON LINE DOYEN A. THE CREW REQUIREMENTS AND RESPONSIBILITIES, PROCESS PARAMETERS, QUALITY AND IN-PROCESS INSPECTIONS, LINE OPERATIONS, PROCESS TROUBLESHOOTING AND RELEVANT DOCUMENTS TO THE PROCESS WERE RUN PER SPECIFICATIONS. THE PROCESS REQUIREMENTS RESULTS WERE DOCUMENTED IN THE MANUFACTURING RECORDS. NO NON-CONFORMANCES, DEVIATIONS OR DISCREPANCIES DURING REVISION OF THE LOT 8C01105 WAS DETECTED REGARDING THE ISSUE REPORTED. RESIDUES OF MASS ACCUMULATED IN THE MIXER EXTRUDER SCREWS REACHING TO THE PRODUCT AS PART OF THE NORMAL MIX OF MASS PROCESS. BASED IN THE ANALYSIS PHASE CONCLUSIONS, THE ISSUE OF BLACK SPOTS ON PRODUCTS REPORTED BY THE CUSTOMERS WAS ATTRIBUTED TO THE FOLLOWING PROBABLE CAUSES: MATERIAL: EMBEDDED SPOTS - ALLOWABLE FOR CMC MATERIAL, PRESENT IN ALL DRESSINGS IN VARYING DEGREES AND EVIDENCE OF PECTIN AND PENTALYN CONTRIBUTING TO SPOTS DUE TO CHANGE COLOR. MACHINE: HIGH TEMPERATURE AT MIXER 06 MAY CAUSE MASS BURNED. CORRECTIVE / PREVENTIVE ACTIONS WILL BE TAKEN FOR EACH FACTOR IDENTIFIED AND WILL BE COVERED THROUGH CORRECTIVE ACTION / PREVENTIVE ACTIONS FORM. 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. REPORTING SITE: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: RETAILER/DEALER/DISTRIBUTOR. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BLACK SPECKS CAN BE SEEN ON THE PRODUCT. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594160 DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187955 8C01105

    Patients

    Seq Age Sex Outcome Treatment
    1