BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EST+ DRNPRECUTINVISICLR35MM(1X10) NAI

    MDR report key: 7660322 · Received July 3, 2018

    Report

    Report Number
    9618003-2018-00512
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EZQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D4: UNIQUE IDENTIFIER (UDI) H6: INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS H10: INVESTIGATION SUMMARY BATCH RECORD REVIEW: LOT 8D01573 WAS MANUFACTURED ON 04/13/2018, APS MANUAL 3 LINE, WITH A TOTAL OF (B)(4) UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 10/05/2020, DESCRIPTION EST+ DRNPRECUTINVISICLR35MM(1X10) NAI 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 1709642 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. RETURNED SAMPLE EVALUATION: THERE ARE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND NO UNUSED RETURN SAMPLE WAS EXPECTED. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED ON THE RESULTS OF THE PRELIMINARY INVESTIGATION, NO HARM WAS REPORTED FROM ANY OF THE COMPLAINANT, ALL DOCUMENTATION REVISED WERE IN ACCORDANCE WITH THE APPLICABLE PROCEDURES. THE TWO COMPLAINTS INCLUDED IN THIS PRELIMINARY INVESTIGATION HAVE PICTURES CONFIRMING THE ISSUE REPORTED. THE SIGNIFICANT RATING OF THIS EVENT IS CONSIDERED MAJOR. DURING THE PRELIMINARY INVESTIGATION CONDUCTED WITH THE MANUFACTURING SUPERVISORS, PROCESS ENGINEER, QUALITY SUPERVISOR FOR THE COMPLAINTS REPORTED DUE TO MALFUNCTION CODE, THE FOLLOWING CONDITIONS WERE EVALUATED, MATERIAL, PERSONNEL, METHOD, ENVIRONMENT AND MACHINE. AFTER THIS ASSESSMENT, THE TRIAGE TEAM IDENTIFIED THE FAILURE OCCURRED DUE TO PERSONNEL, THE COLLAR AND WAFER COMPONENTS ARE MANUALLY PLACED IN THE POUCH BY THE MANUFACTURING PERSONNEL AND DURING THIS PROCESS, PERSONNEL INADVERTENTLY DID NOT PLACE THE COLLAR AND WAFER IN THE CORRECT POSITION. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STARTER HOLE WAS OFF CENTER. NO PHOTO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503733 EST+ DRNPRECUTINVISICLR35MM(1X10) NAI POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC INC 421023 8D01573

    Patients

    Seq Age Sex Outcome Treatment
    1 Female