BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3O0675 - ESTEEM+

    MDR report key: 10934241 · Received December 2, 2020

    Report

    Report Number
    9618003-2020-15465
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 11, 2020
    Report Date
    November 12, 2020
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EZQ
    UDI-DI
    00768455188581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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: NO SAMPLES OR PHOTOS WERE RECEIVED FOR ANALYSIS AND INVESTIGATION; FOR THAT REASON, THE MALFUNCTION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. ON 10/MAY/2021, A BATCH RECORD REVIEW WAS PERFORMED FOR LOT 0F03862. LOT 0F03862 WAS MANUFACTURED ON 6/27/2020 IN THE CONVEX ONE-PIECE LINE, WITH A TOTAL OF (B)(4) MKU. BASED ON THE REVIEW CARRIED OUT, ALL THE APPLICABLE PROCEDURES WERE FOLLOWED, AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BILL OF MATERIALS (BOM), SYSTEM APPLICATION PRODUCT (SAP) MATERIAL 1703636, INTERNATIONAL COMMODITY CODE (ICC) CODE 416749 AND MANUFACTURING ORDER (B)(4). THE PROCESS WAS RUN ACCORDING TO PROCESS INSTRUCTION PI21-076, DOCUMENTED IN THE MR21-076. BATCH RECORD REVIEW CARRIED OUT SUPPORTS THAT NO ISSUES RELATED TO THE PROBLEM WERE IDENTIFIED. IN ADDITION, A COMPLAINT SEARCH FOR LOT 0F03862 AND MALFUNCTION SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G., MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (PRE-CUT ONLY) WAS CARRIED OUT AND AS A RESULT, NO ADDITIONAL COMPLAINTS WERE FOUND; THEREFORE, NO TREND FOR THIS LOT IS OBSERVED. AS PER COMPLAINT MANUFACTURING INVESTIGATION PROCEDURE IT IS NOT REQUIRED TO OPEN A NONCONFORMANCE REPORT (NCR) FOR TYPE 2 COMPLAINTS WHICH WERE NOT CONFIRMED (EITHER BY PHOTOS OR SAMPLES PROVIDED BY THE CUSTOMERS OR RESULTS OF THE BATCH RECORD REVIEW) AND NO POTENTIAL TREND IS IDENTIFIED. THEREFORE, FOR ALL EXPLAINED ABOVE, NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, AS PER PROCEDURE. 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

    DEVICE 6 OF 10. (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 THAT 10 PIECES IN 1 PACKAGE HAD AN OFF CENTERED STARTER HOLE. THE PRODUCTS WERE NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401339 L3O0675 - ESTEEM+ POUCH, COLOSTOMY EZQ CONVATEC DOMINICAN REPUBLIC INC 416749 0F03862 00768455188581

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown