BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 8722684 · Received June 21, 2019

    Report

    Report Number
    9618003-2019-04528
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    June 11, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    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 8K00979 AND MALFUNCTION CODE OST-PMC1.5 (SKIN BARRIER DOES NOT MOLD AROUND STOMA) WAS CARRIED OUT AND AS A RESULT, NO ADDITIONAL COMPLAINT WAS FOUND; THEREFORE, NO TREND IS OBSERVED. AS PER COMPLAINT MANUFACTURING INVESTIGATION PROCEDURE WI-0359, VERSION 4.0, IT IS NOT REQUIRED TO OPEN A NONCONFORMANCE REPORT (NCR) FOR TYPE 2 COMPLAINTS WHICH WERE NOT CONFIRMED. LOT 8K00979 WAS MANUFACTURED ON 10/12/2018 IN THE ATS#2 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLIANCE ENGINEER ID 6053 PERFORMED A BATCH RECORD REVIEW ON 01/18/2020, TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BOM, UNDER SAP MATERIAL 1222277, ICC CODE 411802 AND MANUFACTURING ORDER 1436500. THE CREW REQUIREMENTS AND RESPONSIBILITIES, PROCESS PARAMETERS, QUALITY AND IN-PROCESS INSPECTIONS, LINE OPERATIONS, PROCESS TROUBLESHOOTING AND RELEVANT DOCUMENTS TO THE PROCESS WERE RUN ACCORDING THE PROCESS INSTRUCTION PI21-130. THE PROCESS REQUIREMENTS RESULTS WERE DOCUMENTED IN THE MANUFACTURING RECORDS MR21-130. IN ADDITION, THE BATCH RECORDS OF BULK LOTS 8K00252 AND 8J00904 WERE REVIEWED AND NO ISSUES WERE FOUND; THE LOT RAN ACCORDING TO SAP MATERIAL 1216906, ALL THE TESTING RESULTS WERE FOUND SATISFACTORY. THE PROCESS WAS RUN ACCORDING TO PROCESS INSTRUCTION PI31-123. FURTHERMORE, THE FOLLOWING BULK LOTS MANUFACTURED ON ELC 5 WERE REVIEWED AND NO ISSUES RELATED TO THE MALFUNCTION WERE FOUND: 8J00124, 8H01063, 8D02882, 8J03727, 8F02053, 8J02012, 8H02043, 8H04141, 8H03232, 8J00122 AND 8J00123. THEREFORE, 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. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, SOP-000741. 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

    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

    IT WAS REPORTED THAT THE MASS WAS VERY STIFF AND IT WAS VERY DIFFICULT TO MOLD THE WAFER TO FIT HIS STOMA. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515440 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411802 8K00979

    Patients

    Seq Age Sex Outcome Treatment
    1