BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

    MDR report key: 10448568 · Received August 25, 2020

    Report

    Report Number
    9618003-2020-12970
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    June 4, 2020
    Report Date
    July 30, 2020
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: (B)(6) NO ADDITIONAL ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. BATCH RECORD REVIEW (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR ID 5173 PERFORMED A BATCH RECORD REVIEW ON 07/28/2021 TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BOM AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, UNDER ICC CODE 187955 SAP MATERIAL ID 1704768 AND MANUFACTURING ORDER 1505843. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE COMPLAINT DESCRIPTION AGAINST THE PHOTOGRAPHS PROVIDED BY THE COMPLAINANT BUT, TO DATE NO INFORMATION HAS BEEN RECEIVED. RETURNED SAMPLE EVALUATION: PHOTO RELATED TO THE REPORTED PROBLEM IS AVAILABLE FOR EVALUATION. INVESTIGATION SUMMARY: BASED IN THE ANALYSIS PHASE CONCLUSIONS. METHOD: UNCLEAR STEPS TO PERFORM ONLINE REWORK: AN OPPORTUNITY WAS FOUND SINCE THERE IS NOT A STANDARDIZED METHOD FOR THE SEGREGATION AND/OR REWORK OF THE BLISTERS AFTER HAVING A FAILURE OR BREAKDOWN ON THE CARTONER MACHINE. WRONG PLACEMENT OF BLISTERS (METHOD). DURING THE INDEXATION PROCESS OF BLISTERS FROM THE PRIMARY PACKAGING TO SECONDARY PACKAGING, NOT ALL BLISTERS ARE NOT ORGANIZED INTO THE COUNTER POCKETS. IT IS A MANUAL PROCESS. THIS ISSUE CAUSES THAT THE BLISTERS DO NOT ENTER ON THE MKU¿S, CREATING DEFECTS SUCH AS TORN OR CRUSHED OR DIRTY PACKAGE. 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

    DEVICE 4 OF 7. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE COMPLAINT DESCRIPTION AGAINST THE PHOTOGRAPHS PROVIDED BY THE COMPLAINANT BUT, TO DATE NO INFORMATION HAS BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ¿DIRTY PACKAGING.¿ THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913700 DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187955 9L01731

    Patients

    Seq Age Sex Outcome Treatment
    1