BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

    MDR report key: 7245387 · Received February 6, 2018

    Report

    Report Number
    9618003-2018-00006
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 24, 2018
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DEVICE MANUFACTURE DATE. RECEIVED ONE HUNDRED (100) UNUSED DUODERM EXTRA THIN DRESSING 10CM X 10CM ON 03/01/2018. THE RETURN PRODUCT DID APPEAR TO HAVE BLACK SPOTS ON HYDROCOLLOID LAYER BASED ON VISUAL INSPECTION. MANUFACTURING SITE RECEIVED ONE LARGE BOX CONTAINING TWENTY-FOUR (24) MARKET UNITS (MKU) OF LOT 7E04765 WERE RECEIVED ON 03/01/2018. EACH MKU CONTAINED 10 SEALED INDIVIDUAL SAMPLES. UPON INSPECTION 20 SAMPLES, ALL OF THEM WITH DARK PARTICLES: 1 / 20 FAILED. THE REMAINING TWENTY (20) MKU¿S RECEIVED WERE VISUALLY INSPECTED: ALL OF THEM HAD INDIVIDUAL UNITS WITH VERY TINY DARK PARTICLES IN THEM, AND ONE (1) OF THEM WAS GREATER THAN 0.1 MM2 IN SIZE. ON APRIL 10, 2018, A QUERY REVIEW OF THE HISTORICAL DATA SHOWED THAT NO ADDITIONAL SIMILAR COMPLAINTS HAD BEEN REPORTED FOR LOT 7E04765. IN ADDITION, THE QUERY REVEALED THAT THE FOUR (4) COMPLAINTS WERE REPORTED BY THREE (3) DIFFERENT CUSTOMERS, ALL THREE FROM KOREA. THE MASS RAW MATERIAL (COMPONENT # 1002207) IS MIXED AND TAKEN TO THE ELC10 MACHINE FOR THE LAMINATING PROCESS, WHERE THE MASS IS CUT IN THIN LAYERS TO MAKE THE DRESSING: MATERIAL # 1003411: DRESSING XTHIN DDERM W/PET 10X10CM. THE DRESSING UNITS ARE VISUALLY INSPECTED AT THE END OF THE ELC10 PROCESS, LOOKING FOR ANY IRREGULARITY. THESE UNITS ARE THEN PUT IN TRAYS WHICH, ARE THEN TRANSPORTED TO THE BODOLAY LINE FOR THE FINAL ASSEMBLY AND PACKAGING OPERATIONS. A BATCH RECORD REVIEW WAS PERFORMED ON APRIL 10, 2018 BY A MULTIDISCIPLINARY TEAM, FOR LOT 7E04765, ORDER 1349990. THIS LOT WAS MANUFACTURED ON 13 JUNE 2017 AT THE BODOLAY LINE: 1,350 MARKET UNITS (MKU) WERE MANUFACTURED. THE BATCH RECORD DOCUMENTATION SHOWS THAT NO INCIDENTS RELATED TO THE REPORTED CONDITION. IN ADDITION, BATCH RECORDS FOR TWO DRESSING COMPONENT LOTS (7E04860 AND 7F03452) WERE REVIEWED. BOTH DRESSING LOTS WERE PROCESSED AT THE ELC10 LINE AND NO IRREGULARITIES WERE REPORTED. IN ADDITION, THE BATCH RECORDS FOR THE MASS RAW MATERIAL LOTS USED (LOTS 7E04377 AND 7F03474) WERE REVIEWED AND NO RELATED IRREGULARITIES WERE FOUND EITHER. THE MASS RAW MATERIAL USED WAS MATERIAL # 1002207, WHICH IS VIRGIN (UNRECYCLED) MASS. BASED ON THE SAMPLES EVALUATION TAPPI CHART INSPECTION RESULTS, THE REPORTED CONDITION IS CONFIRMED. FOUR (4) COMPLAINTS WERE REPORTED FOR LOT 7E04765, ICC CODE 187955, PRODUCT DUODERM XTHIN DRS 10X10CM (1X10PK) NAI. PICTURES ATTACHED TO TWO OF THE COMPLAINT PARENT RECORDS IN TRACKWISE 8.7 SHOW THE REPORTED CONDITION; AND BASED ON THE EVALUATION OF THE SAMPLE THE NONCONFORMANCE WAS CONFIRMED. THE DARK PARTICLES ARE MOST LIKELY BURNT MASS RESIDUE, ORIGINATED AT THE MASS MIXING STATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTING SITE: 1049092 MANUFACTURING SITE: 9618003

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION.   ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER 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 BY THE STAFF THAT BLACK SPOTS WERE FOUND ON THE HYDROCOLLOID LAYER OF DUODERM EXTRA THIN UPON OPENING SEVERAL BOXES. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT. NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88218 DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING DRESSING,WOUND,OCCLUSIVE NAD 187955 7E04765

    Patients

    Seq Age Sex Outcome Treatment
    1