BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM PASTE AND GELS

    MDR report key: 18502911 · Received January 12, 2024

    Report

    Report Number
    1000317571-2024-00003
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Report Date
    December 20, 2023
    Manufacturer
    CONVATEC LTD
    Product Code
    NAE
    UDI-DI
    00768455172979
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6 - INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS. H10: INVESTIGATION SUMMARY. A BATCH RECORD REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE FOUND. DUODERM H/ACTIVE GEL (3TBEX30G) STER US WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1002859 AND MANUFACTURING LOT NUMBER 3C03443 ON 25 APRIL 2023. SYSTEM APPLICATION PRODUCT (SAP) STATES THE MANUFACTURE DATE AS 19 APRIL 2023, BUT THE BATCH RECORD CONFIRMS THE MANUFACTURE DATE AS 25 APRIL 2023. LOT # 3C03443 WAS STERILIZED UNDER ANDERSEN CALEDONIA BATCH SSP210323-1 AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION PROVIDED BY STERILIZATION COMPANY ANDERSEN CALEDONIA. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. NO NONCONFORMITY WAS IDENTIFIED DURING THE MANUFACTURING PROCESS OF LOT 3C03443. THIS IS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE. TWO PHOTOGRAPHS WERE RECEIVED FOR THIS ISSUE AND HAVE BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTIONS (WI). THE PHOTOGRAPHS CONFIRM THE EXPECTED LOT NUMBER, PRODUCT AND THE COMPLAINT ISSUE WHERE AN AREA OF DISCOLORATION CAN BE SEEN ON THE GEL TUBE. A NONCONFORMANCE WAS NOT OPENED FOR THIS COMPLAINT ISSUE, AS THE ALUMINIUM TUBES FOR THE GEL PRODUCT IS SUPPLIED BY AN EXTERNAL SUPPLIER. THE SUPPLIED MATERIAL (1024928G1) WAS SUPPLIED BY SUPPLIER PHARMATUBE. ORDINARILY, A SCAR (SUPPLIER CORRECTIVE ACTION REPORT) WOULD BE RAISED FOR SUPPLIER PHARMATUBE, BUT PHARMATUBE ARE NO LONGER TRADING AND ARE IN ADMINISTRATION. AS SUCH, THE RESOLUTION OF THIS ISSUE WITH THE SUPPLIER IS NOT POSSIBLE AS THEY ARE CEASING TRADING AND WOULD BE UNABLE TO INVESTIGATE, IDENTIFY ISSUES OR RESUPPLY. SIMILAR ISSUES RELATING TO THE QUALITY OF THE GEL TUBES THEMSELVES ARE ALSO NOT POSSIBLE TO BE RESOLVED. A NEW SUPPLIER FOR THE GEL TUBES IS BEING SOURCED AND VALIDATED. AS NO FURTHER INVESTIGATION IS POSSIBLE, THE COMPLAINT INVESTIGATION WILL BE CLOSED. ANY FURTHER COMPLAINTS RECEIVED FOR THE GEL TUBES THAT REQUIRE SUPPLIER INVESTIGATION WILL BE UNABLE TO PROGRESS. AS THE TUBES ARE MADE OF ALUMINIUM, THE YELLOWING OF THE TUBE IS MOST LIKELY A DISCOLOURATION OF THE LACQUER, WHICH CAN HAPPEN DURING THE STERILIZATION PROCESS IF STEAM EXPLOITS AN INDENT OR DAMAGE TO THE TUBE. THERE IS A SLIGHT INDENT INTO THE LACQUER LAYER, BUT IS NOT LIKELY TO BE A PIERCING IN THE TUBE AS THERE IS NO EVIDENCE OF GEL LEAKING. THIS IS THEREFORE A COSMETIC ISSUE AND IT IS LIKELY THE GEL IS SAFE TO USE AS THERE HAS BEEN NO BREACH IN THE PRIMARY PACKAGE. 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. FDA REGISTRATION NUMBER REPORTING SITE: 1049092, MANUFACTURING SITE: 1000317571.

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT STREET ADDRESS: (B)(6).COMPLAINANT CITY: (B)(6).COMPLAINANT STATE: (B)(6).COMPLAINANT COUNTRY: (B)(6).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: 1049092. MANUFACTURING SITE: 1000317571.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED BY DISTRIBUTOR THAT THEY FOUND PERFORATION AND STAIN IN PRIMARY PACKAGE MATERIAL. THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059006 DUODERM PASTE AND GELS DRESSING, WOUND, HYDROGEL WITHOUT DRUG AND/OR BIOLOGIC NAE CONVATEC LTD 187987 3C03443 00768455172979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown