BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 15493401 · Received September 27, 2022

    Report

    Report Number
    9618003-2022-05101
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Report Date
    September 1, 2022
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    UDI-DI
    00768455150922
    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 PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: ¿ THERE ARE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. BATCH RECORD REVISION RESULTS: LOT 1L01362 WAS MANUFACTURED ON 11/NOV/2021, IN BODOLAY LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 25/SEP/2023, TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BILL OF MATERIALS (BOM) AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL ID 1704768 AND MANUFACTURING ORDER (B)(4). THE PRODUCTION PROCESS, IN-PROCESS CONTROL, TESTING RESULTS AND PACKAGING OF PRODUCTS WAS RUN ACCORDING TO THE PROCESS INSTRUCTION PI31-142 (CHEVRON SLEEVE AUTOMATIC PACKING LINE BODOLAY). BULK DRESSING BATCH RECORD REVISION: DURING THE MANUFACTURING PROCESS OF AFFECTED LOT 1L01362, WERE USED BULK DRESSING LOT 1K04610, 1L00738 AND 1K04608. THESE BULK LOT WERE MANUFACTURED IN ELC#11 MANUFACTURING LINE. NO DISCREPANCIES RELATED TO THE ISSUE REPORTED WERE FOUND DURING THE MANUFACTURING PROCESS OF THESE BULK LOTS. THE PRODUCTION PROCESS, IN-PROCESS CONTROL, TESTING RESULTS AND PACKAGING OF PRODUCTS WAS RUN ACCORDING TO THE PROCESS INSTRUCTION (PI) AND BR31-141 (BATCH RECORD FOR ELC#11). BULK MASS BATCH RECORD REVISION: DURING THE MANUFACTURING PROCESS OF AFFECTED LOT 1L01362, WERE USED BULK MASS LOT 1K03512, 1K03038, 1K04205, 1K04207, 1L00372 AND 1L00373. THESE BULK LOTS WERE MANUFACTURED IN ROPING DURAHESIVE MIX MANUFACTURING LINE. NO DISCREPANCIES RELATED TO THE ISSUE REPORTED WERE FOUND DURING THE MANUFACTURING PROCESS OF THESE BULK LOTS. THE PRODUCTION PROCESS, IN-PROCESS CONTROL, TESTING RESULTS AND PACKAGING OF PRODUCTS WAS RUN ACCORDING TO THE PROCESS INSTRUCTION (ROPING ADHESIVE MASS PROCESS INSTRUCTIONS). REVIEW OF THE BATCH RECORDS SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. HISTORICAL COMPLAINTS REVIEW: ON 25/SEP/2023, COMPLAINT INVESTIGATOR RAN A QUERY IN DATABASE FROM 01/JAN/2022 TO 25/SEP/2023 IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE LOT NUMBER 1L01362 FOR THE MALFUNCTION CODE ¿ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E., DIFFICULT TO REMOVE)¿ AND AS RESULT, NO ADDITIONAL COMPLAINTS WERE FOUND. HISTORICAL NONCONFORMANCE REVIEW: ON 25/SEP/2023, COMPLAINT INVESTIGATOR RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA (S) ASSOCIATED TO THE MALFUNCTION CODE ¿ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E., DIFFICULT TO REMOVE)¿ FOR THE LOT NUMBER 1L01362 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA (S) FOR THIS MALFUNCTION CODE WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOT. CURRENT QUALITY CONTROLS: BASED ON THE PROCESS INSTRUCTION (PI31-141), THE FOLLOWING TESTS ARE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: TEST METHODS (TM-011) ¿ADHESIVE TACK TESTS - METHOD 2: ¿ FREQUENCY: ONCE PER SHIFT OR IF SETTINGS CHANGED. ¿ SAMPLE QUANTITY: 2 SAMPLES. ¿ SPECIFICATION: NMT 1¿ TRAVEL. ¿ ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1. DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 81 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE OF 270,000 PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY 0.03% WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR ADHESIVE ISSUES WHICH SHOULD BE 0.65% BASED ON OUR STANDARD OPERATING PROCEDURE (SOP). IN ADDITION, ALL OF THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND AN ADHESIVE ISSUES, WHICH CONFIRMS THAT THE LOT IS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF 0.65. THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: THERE ARE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE SEEN AND CONFIRMED. THE REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE AFFECTED LOT FOR THE MALFUNCTION CODE ¿ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E., DIFFICULT TO REMOVE)¿. NO ADDITIONAL COMPLAINTS WERE REPORTED FOR LOT AFFECTED RELATED TO THE MALFUNCTION CODE ¿ADHESIVE DRESSING REQUIRES EXCESSIVE FORCE FOR REMOVAL FROM SKIN (I.E., DIFFICULT TO REMOVE)¿. BASED ON THIS, NO NEGATIVE TREND WAS IDENTIFIED. 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: 9618003.

    Additional Manufacturer Narrative · 0

    DEVICE 9 OF 14. AS PER THE INFORMATION PROVIDED BY COMPLAINANT, FOR THE ISSUE DRESSING TOO STICKY, THE IMDRF MED. DEV. PROB. CODE: (B)(4) (ADHESIVE TOO STRONG) IS NOT AVAILABLE FOR SELECTION. INITIAL REPORTER NAME AND ADDRESS: COMPLAINANT STREET ADDRESS: (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: (B)(4).

    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 RETAILER THAT THE COMPLAINT WAS RECEIVED FROM A MEDICAL COSMETIC CENTER AND THE PATIENT ABOUT DRESSING TOO STICKY WHICH CAUSED SKIN RED AND SWOLLEN AFTER REMOVAL. THE PATIENT WAS UPSET AND NOT WILLING TO USE THE PRODUCT. THE PHOTOGRAPHS AND VIDEO DEPICTING THE ISSUE WERE ALSO RECEIVED FROM THE COMPLAINANT. PATIENT WENT TO COSMETIC CENTER AND RECEIVED ELECTROCAUTERIZATION PRIOR TO THE APPLICATION OF DRESSING, THEN THE DRESSING WAS APPLIED, HOWEVER, REMOVAL OF DRESSING WAS TOO STICKY AS COMPARED TO PREVIOUS DRESSING EXPERIENCE AND IT CAUSED SKIN RED AND SWOLLEN. THERE WAS NO TREATMENT PROVIDED, ONLY BASIC CLEANSING WAS DONE WITH POVIDONE-IODINE AND MEDICINE WERE NOT USED. THE TOTAL DRESSINGS USED ON THE PATIENT WERE FOURTEEN AND REMAINING SIXTY-SEVEN WERE RETURNED BY MEDICAL COSMETIC CENTER DUE TO THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363393 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187955 1L01362 00768455150922

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown