BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W1275 - DUODERM PASTE AND GELS

    MDR report key: 13106752 · Received December 29, 2021

    Report

    Report Number
    1000317571-2021-00255
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Report Date
    November 29, 2021
    Manufacturer
    CONVATEC LTD
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 1 OF 3. CONTACT OFFICE ADDRESS: (B)(4). 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. FDA REGISTRATION NUMBER REPORTING SITE: (B)(4), MANUFACTURING SITE: (B)(4).

    Additional Manufacturer Narrative · 0

    A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. NO NONCONFORMITY WAS REGISTERED DURING THE MANUFACTURING PROCESS OF LOT 0B02944. GRANUFLEX H/COLLOID PASTE 30G WAS MANUFACTURED UNDER SAP CODE 1181514 AND MANUFACTURING LOT NUMBER 0B02944. LOT # 0B02944 WAS STERILIZED UNDER LOT 2173-8209A AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY STERIS. ALL RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. THIS BATCH HAS PREVIOUSLY BEEN REPORTED UNDER COMPLAINT. THIS IS THE FIFTH COMPLAINT RECEIVED AGAINST BATCH 0B02944 (PREVIOUS COMPLAINTS: (B)(4) AND IS THE THIRD COMPLAINT FOR THIS BATCH AND MALFUNCTION CODE (WND-PMC09.06 PRIMARY PACK (STERILE PRODUCTS) HAS INCOMPLETE OR OPEN SEAL / WELD, OR IS TORN, RIPPED OR CONTAINS HOLES OR EXHIBITS EXTERNAL CONTAMINATION (E.G. WATER MARKS, STAINS), OR DRESSING OR LOOSE MATERIAL IS TRAPPED IN PACKAGING). ONE PHOTOGRAPH HAS BEEN RECEIVED FOR THIS COMPLAINT AND HAS BEEN EVALUATED IN ACCORDANCE WITH WI-(B)(4). THE PHOTOGRAPH SHOWS 3 SECONDARY PACK CARTONS WHICH APPEAR DISCOLOURED AND YELLOWED. THE PRODUCT SHOWN IS THE EXPECTED PRODUCT, BUT THE LOT NUMBER IS NOT DISPLAYED. NO IMAGES OF THE PRIMARY PACK ARE AVAILABLE, AND THEREFORE THE PART OF THE COMPLAINT PERTAINING TO THE GREASY APPEARANCE OF THE PRIMARY PACK CANNOT BE CONFIRMED. THE ISSUE REPORTED HAS BEEN SEEN BEFORE, AND THE YELLOWING OF THE SECONDARY PACK APPEARS TO BE A RESULT OF EXCESS PASTE WITHIN THE CRIMP OF THE TUBE WHICH HAS LEAKED ONTO THE SECONDARY CARTON GIVING IT A YELLOW, GREASY APPEARANCE. DUODERM PASTE HAS SINCE BEEN DISCONTINUED AND THE LINE HAS BEEN REMOVED FROM DEESIDE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 1000317571.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS CONTAINER LEAKAGE WHICH WAS EVIDENT PRIOR TO USE. THE TUBES WERE NOT DAMAGED AND THERE WAS NO VISIBLE CUT OR CRACK ON PRIMARY PACKAGE, BUT THE SECONDARY AND PRIMARY PACKAGING WAS GREASY TO TOUCH. IT WAS UNKNOWN IF THE PRODUCT WAS USED BY THE END USER. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003173 L3W1275 - DUODERM PASTE AND GELS NOT APPLICABLE NAD CONVATEC LTD 187930 0B02944

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown