BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 16806163 · Received April 25, 2023

    Report

    Report Number
    9618003-2023-00411
    Event Type
    Malfunction
    Date Received
    April 25, 2023
    Report Date
    March 31, 2023
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455124497
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 RETURNED SAMPLE EVALUATION: NO PHOTOGRAPH ASSOCIATED WITH THIS CASE WAS RECEIVED FOR EVALUATION. BATCH RECORD REVIEW: THE LOT 2K01777 WAS MANUFACTURED ON 20/OCT/2022 CONVEX 2-PIECE (PC) MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 21/JUL/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 1161268 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. INVESTIGATION SUMMARY: THIS ISSUE IS RELATED TO OFF CENTER ISSUES. THE SCOPE OF THIS INVESTIGATION COVERS ALL PRODUCT FAMILY MANUFACTURED IN CONVEX 2PC LINE. THIS COMPLAINT HAS BEEN EVALUATED FOR MDR REPORTABILITY USING WI-0361 MDR PROCEDURE WORK INSTRUCTION. THE 30-DAY MDR REPORTABILITY DECISION FOR THIS COMPLAINT IS YES. THERE WAS NO HARM REPORTED WITH THIS COMPLAINT. THE PRODUCT MALFUNCTION IS OST-PMC01.08, SEVERITY 4. THE COMPLAINT AS DESCRIBED HAS BEEN REVIEWED AND DOES NOT REPRESENT A THREAT TO PUBLIC SAFETY AND THEREFORE DOES NOT WARRANT A 5-DAY REPORT TO THE FDA PER 21 CFR PART 803. THIS EVENT IS CONSIDERED SYSTEMIC BASED ON THE INCREASE OF COMPLAINTS REPORTED FROM 01/JAN/2022 TO 31/DEC/2022, ADDITIONAL ELEVEN (11) HARM ALERT WERE REPORTED BY THREE DIFFERENT COMPLAINANTS AND DIFFERENT PERIOD, IN ADDITION IT WAS IDENTIFIED A NONCONFORMANCE REPORT BEFORE THIS INVESTIGATION PROCESS. BASED ON THAT, ACTIONS WILL BE TAKEN TO MITIGATE THE FAILURE MODE REPORTED. REFER TO THE PROCESS INSTRUCTION (PI) AND MANUFACTURING LINES IMPACTED IN THIS NONCONFORMANCE BELOW: CONVEX 2-PIECE (PC) (PROCESS INSTRUCTION (PI) CONVEX 2-PIECE (PC) WAFER SUB-ASSEMBLY MACHINE 2 COLLARING OPERATIONS). AFTER 6 METHODOLOGIES (MS) ANALYSIS WAS IDENTIFIED. CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN FOR EACH OF THE CAUSES IDENTIFY FOR PROBLEM SOLUTION. REFER TO CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) PLAN RECORD IN DATABASE. THE INVESTIGATION HAS BEEN APPROVED AND IS COMPLETE. 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.

    Additional Manufacturer Narrative · 0

    DEVICE 4 OF 5. 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: 9618003.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    THE END USER REPORTED THAT THE FIVE WAFERS FROM A MARKET UNIT FOUND PRE-CUT HOLE SIGNIFICANTLY OFF CENTERED PRIOR TO USE AND SHE FELT THAT THIS ISSUE MADE THE WAFERS UNUSABLE. SHE STATED THE USUAL WEAR TIME OF SEVEN DAYS. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489507 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 413179 2K01777 00768455124497

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown