BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W0750 - DUODERM

    MDR report key: 13547574 · Received February 17, 2022

    Report

    Report Number
    9618003-2022-00174
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Report Date
    January 21, 2022
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES OR PHOTOS WERE RECEIVED FOR ANALYSIS AND INVESTIGATION; FOR THAT REASON, THE MALFUNCTION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. IN ADDITION, A COMPLAINT SEARCH FOR LOT 1C01811 AND MALFUNCTION CODE (B)(4) ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E. DIFFICULT TO REMOVE) WAS CARRIED OUT AND AS A RESULT, NO ADDITIONAL COMPLAINT WAS FOUND; THEREFORE, NO TREND IS OBSERVED. AS PER COMPLAINT MANUFACTURING INVESTIGATION PROCEDURE WI-(B)(4) VERSION 5.0, IT IS NOT REQUIRED TO OPEN A NONCONFORMANCE REPORT (NCR) FOR TYPE 2 COMPLAINTS WHICH WERE NOT CONFIRMED. LOT 1C01811 WAS MANUFACTURED ON 03/31/2021, DOYEN B, WITH A TOTAL OF (B)(4) UNITS. A BATCH RECORD REVIEW WAS PERFORMED 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. SAP MATERIAL 1000915 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. 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

    IT WAS REPORTED THAT THE PATIENT USED THE DRESSING WHICH WAS HARD TO REMOVE FROM SKIN BECAUSE OF ITS TOO STRONG ADHESIVENESS. NO PHOTO IS AVAILABLE AT THIS TIME

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942302 L3W0750 - DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187955 1C01811

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown