BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L3O0200 - NATURA

    MDR report key: 12771669 · Received November 8, 2021

    Report

    Report Number
    9618003-2021-02655
    Event Type
    Injury
    Date Received
    November 8, 2021
    Report Date
    October 11, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EZQ
    UDI-DI
    00768455182411
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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: CORRECTION (G1) - CONTACT OFFICE ADDRESS: (B)(4). BATCH RECORD REVIEW: LOT 7H00390 WAS MANUFACTURED ON 09/AUG/2017, IN THE 11E MANUFACTURING LINE WITH A TOTAL OF (B)(4). COMPLAINT INVESTIGATOR ID (B)(4) PERFORMED A BATCH RECORD REVIEW ON 18/NOV/2021, TO VERIFY 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 WAS ALSO CORRECT, SAP MATERIAL ID 1003643 AND MANUFACTURING ORDER (B)(4). NO DISCREPANCIES RELATED TO THE ISSUE REPORTED WERE FOUND. RETURNED SAMPLE EVALUATION: NO PHOTOS WERE RECEIVED AND NO UNUSED RETURN SAMPLES WERE EXPECTED. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED ON THE PRELIMINARY INVESTIGATION PERFORMED, NO ISSUES RELATED TO THE CUSTOMER EXPERIENCE WERE FOUND IN THE BATCH RECORD REVIEW. NO SIGNIFICANT CHANGES HAVE BEEN MADE IN THE PROCESS OR IN THE PRODUCT COMPONENTS THAT COULD CAUSE THE ADVERSE EFFECTS REPORTED BY THE CUSTOMER. THE PRODUCT WAS USED IN THEIR SHELF LIFE. NO PHOTOS OR SAMPLES WERE RECEIVED AND PER CUSTOMER DESCRIPTION THERE IS NOT ENOUGH INFORMATION ABOUT HOW THE PRODUCT WAS USED THAT LEADS US TO A CONCLUSION, THEREFORE, THERE IS NOT PRODUCT MALFUNCTION CONFIRMED. IN ADDITION, PER CUSTOMER DESCRIPTION, THE CAUSE OF URINARY TRACT INFECTION REPORTED FOR LOT 7H00390 IS RELATED TO THE CLIP CRACK/BREAK AND THIS DEFECT WAS ADDRESSED BY ANOTHER THE RECORD IN THE DATABASE. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT WAS APPROVED AND 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

    MDR 9618003-2021-02655 / DEVICE 2 OF 2. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. 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 · 0

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

    Description of Event or Problem · 0

    THE END USER REPORTED THAT SHE DEVELOPED URINARY TRACT INFECTION (UTI). LABORATORY TESTS SHOWED E-COLI IN URINE AND WAS STARTED ON AN UNKNOWN ANTIBIOTIC. NO PHOTO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666215 L3O0200 - NATURA POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC INC 401502 7H00390 00768455182411

    Patients

    Seq Age Sex Outcome Treatment
    1 Female