BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3O0200 - NATURA

    MDR report key: 11606835 · Received April 2, 2021

    Report

    Report Number
    9618003-2021-00519
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 7, 2021
    Report Date
    March 7, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: DR. (B)(4). PHOTO RELATED TO THE REPORTED PROBLEM IS AVAILABLE FOR EVALUATION. ON (B)(6) 2021 A QUERY WAS RUN BY COMPLAINT INVESTIGATOR ID (B)(4) FROM (B)(6) 2018 UP TO (B)(6) 2021 IN TRACKWISE 8.7 SYSTEM, ASSOCIATED TO MALFUNCTION OST-PMC1.14 SKIN BARRIER IN CONTACT WITH SKIN IS TOO ROUGH OR SHARP, SHARP EDGES AT STOMA MAY OCCUR AND SIX (6) COMPLAINTS WERE IDENTIFIED (REFER TO ATTACHMENT#1). WAFER FEELS THINNER RESULTING IN A LACERATION OF THE STOMA AND NO CONSISTENCY WITH FLANGES, SOME ARE NOT CENTRAL AND IRREGULARITIES WITH THE PRE-CUT HOLE HAVING JIGGERED EDGES. WHAT IS THE EXTEND OF THE NC? THIS DOCUMENT HAS BEEN CREATED TO PERFORM THE PRELIMINARY INVESTIGATION FOR COMPLAINTS, LOT NUMBER, ICC AND SAP MATERIAL LISTED IN ATTACHMENT#1 WITH MALFUNCTION OST-PMC1.14 SKIN BARRIER IN CONTACT WITH SKIN IS TOO ROUGH OR SHARP, SHARP EDGES AT STOMA MAY OCCUR, WITH SEVERITY RATING 4. THE SCOPE OF THIS NONCONFORMANCE REPORT IS TO COVER THE AL PRODUCTS MANUFACTURED IN THE MLK#2, MLK#3, MLK#6ANN CONVEX 2PC AUTO LINES. THE FOLLOWING FIGURE#1 SHOWS THE MANUFACTURING LINES WITH EIGHT (8) COMPLAINTS REPORTED RELATED TO MALFUNCTION CODE OST-PMC1.14 FROM (B)(6) /2018 UP TO (B)(6) 2021. THE FIGURE#2 BELOW SHOWS COMPLAINTS REPORTED BY MANUFACTURING DATE FROM (B)(6) 2018 UP TO (B)(6) 2021 WITH MALFUNCTION CODE OST-PM1C.14: BATCH RECORDS REVIEW: BATCH RECORDS REVIEW WAS PERFORMED BY COMPLAINT INVESTIGATOR ID (B)(4) FOR THE AFFECTED LOTS NUMBER LISTED IN THE ATTACHMENT#1. A TOTAL OF FIVE (5) LOTS NUMBER WERE VERIFIED TO CONFIRM 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. PROCESS DESCRIPTION: THE WAFER USED DURING THE MANUFACTURING PROCESS OF THE AFFECTED LISTED IN ATTACHMENT#1 ARE PRODUCED IN ELC#4 LINE. PI31-033 (EXTRUSION, LAMINATION AND CUTTING ELC4) VER. 19.0). STICKS OF ADHESIVE MASS ARE PLACED IN THE OPENING OF THE EXTRUDER. THE MASS IS CARRIED BY A SCREW THROUGH FROM THE BARREL CHAMBER AND PUSHED THROUGH AN OPENING IN THE DIE. THE EXTRUDATE IS BROUGHT TO THE THICKNESS SPECIFICATION AND IS THEN LAMINATED BETWEEN A TOP AND BOTTOM LAYER OF SILICONE RELEASE PAPER. THE TOP OF THE SILICONE RELEASE PAPER IS REMOVED, AND A POLYETHYLENE FILM IS USED TO LAMINATE THE ADHESIVE SURFACE. THE THREE LAYERS (PAPER, POLYETHYLENE AND MASS) ARE COOLED AND CARRIED THROUGH A ROTARY CUTTER, WHERE THEY ARE CUT ACCORDING TO SPECIFICATIONS. THE FINISHED WAFERS SON INSPECTED AND STACKED IN TRAYS TO BE PLACED IN A FINISHED PRODUCT CART TO AWAIT THE NEXT OPERATION. THE CALENDER IS ADJUSTED TO EXTRUDE THE MASS PER PROCESS SPECIFICATIONS, THICKNESS TEST IS PERFORMED BEFORE INITIATED THE MANUFACTURING PROCESS. INDIVIDUAL THICKNESS TEST (INCLUDING SRP) IS PERFORMED AND MUST COMPLY WITH THE SPECIFICATION REQUIREMENTS 0.075" ± 0.005"1.91MM ± 0.127MM AND FOR URIHESIVE STRIPS 0.071" ± 0.005"1.80MM ± 0.130MM. THICKNESS TEST WAS PERFORMED IN ELC#4 MANUFACTURING LINE WITH SATISFACTORY RESULTS 0.074MM, 0.75MM AND 0.76MM WITHIN ESTABLISHED REQUIREMENTS PER PI31.033. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. HISTORY DATA REVIEW: TWO YEAR QUERY, SINCE (B)(6) 2018 UP TO (B)(6) 2021 WAS RUN IN TRACKWISE SYSTEM BY COMPLAINT INVESTIGATOR ID (B)(4) TO DETERMINE A TREND OF FAILURE MODE OST-PMC1.14 SKIN BARRIER IN CONTACT WITH SKIN IS TOO ROUGH OR SHARP, SHARP EDGES AT STOMA MAY OCCUR, SIX (6) COMPLAINTS WERE IDENTIFIED AND WILL BE COVER IN THIS INVESTIGATION. NO TRACKWISE RECORD EVENT (PROCESS NCRS) WAS IDENTIFIED DURING THE PERIOD (B)(6) 2018 UP TO (B)(6) 2021. PRELIMINARY INVESTIGATION CONCLUSION: BASED ON THE INFORMATION ABOVE, NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS AS PER THE BATCH RECORDS REVIEW FOR THE AFFECTED BATCHES LISTED IN ATTACHMENT#1 AND THICKNESS TEST WAS PERFORMED PER PROCESS SPECIFICATION WITH SATISFACTORY RESULTS.NO ADDITIONAL ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(6). (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. (B)(4).

    Description of Event or Problem · 1

    THE END USER REPORTED THAT THE INNER EDGES OF THE WAFER WERE JAGGED AND UNEVEN PRIOR TO USE (BEFORE CUTTING THE WAFER TO FIT THE STOMA). THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506953 L3O0200 - NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 125265 0G03682

    Patients

    Seq Age Sex Outcome Treatment
    1