BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM+

    MDR report key: 15951576 · Received December 9, 2022

    Report

    Report Number
    1049092-2022-00420
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Report Date
    November 17, 2022
    Manufacturer
    CONVATEC INC
    Product Code
    EXG
    UDI-DI
    00768455197859
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: POUCH, COLOSTOMY. PRODUCT CODE: EZQ. COMPLAINANT STATE/PROVINCE: KANAGAWA EVENT COUNTRY: JAPAN. PMA /510(K) #: EXEMPT. 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: 1049092.

    Additional Manufacturer Narrative · 0

    E1: COMPLAINANT STATE/PROVINCE:(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. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. THIRD PARTY MANUFACTURING SITE (FOR LIFE): 3003759552.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED FOR THIS COMPLAINT BY THE ASSIGNED MANUFACTURING SITE INVESTIGATION TEAM. THE COMPLAINT SUMMARY OF THIS INVESTIGATION REQUIRED REWORK. A CORRECTIVE ACTIONS/PREVENTIVE ACTIONS (CAPA) WAS RAISED, AND AN UPDATED/CORRECTED INVESTIGATION SUMMARY HAS BEEN COMPLETED IN ACCORDANCE WITH ASSIGNED CAPA. A SUPPLEMENTAL MDR IS BEING SUBMITTED TO DOCUMENT THE COMPLETION OF INVESTIGATION REWORK AND FINAL INVESTIGATION; THE COMPLAINT RECORD WILL PROCEED TO CLOSURE. LOT 0000620231 WAS MANUFACTURED ON 01/01/2022 AND THIS WAS THE ONLY COMPLAINT FOUND IN DATABASE. HENCE, NO FULL CAUSE INVESTIGATION WAS CARRIED OUT. THIS LOT WAS NOT RELATED TO FIELD SAFETY NOTICE (FSN) ISSUED IN 2019. NO RETURN SAMPLES WERE PROVIDED. 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. THIRD PARTY MANUFACTURING SITE (FOR LIFE): 3003759552.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE WAFER WAS NOT CUT ENOUGH. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2908931 ESTEEM+ BAG, URINE COLLECTING, URETEROSTOMY EXG CONVATEC INC 422545 0000620231 00768455197859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown