BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 8856568 · Received August 2, 2019

    Report

    Report Number
    9618003-2019-04899
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT HAS BEEN EVALUATED AS A TYPE 2 (CRITICAL), THE INVESTIGATION ASSOCIATED WITH RELATED EVENT 1077382 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, SOP-000741. BATCH RECORD REVIEW LOT 8G01431 WAS MANUFACTURED ON 07/18/2018, LINE CONVEX 2 PC 2, WITH A TOTAL OF (B)(4) MARKET UNITS. A BATCH RECORD REVIEW WAS PERFORMED 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, UNDER ICC CODE 404592 SAP MATERIAL 1156500 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. THERE ARE NO PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND NO UNUSED RETURN SAMPLE WAS EXPECTED. INVESTIGATION CONCLUSION BASED ON THE INVESTIGATION FINDINGS THROUGH REVISION OF THE BATCH RECORDS DOCUMENTATION, PROCESS OBSERVATION, PERSONNEL INTERVIEWED, METHODOLOGY IMPLEMENTED AND DEFECTS SIMULATION, THE SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. NEVERTHELESS, THERE ARE SEVEN (07) CONDITIONS THAT COULD BE CONSIDERED, BASED ON OBJECTIVE EVIDENCES AND EXPERTISE, AS CONTRIBUTOR FACTORS FOR THIS EVENT AND, ONE (01) OPPORTUNITIES FOR IMPROVEMENT WERE FOUND: 1. MATERIALS INVESTIGATIONS: FABRIC ROLLS NOT ROLLED UNIFORMLY. NO WELDED OR OVER WELDED FLANGES. 2. PROCESS/METHODS INVESTIGATION: WRONG ADHESIVE TAPE USED FOR JOINT FABRICS ROLLS. OPPORTUNITIES FOR IMPROVEMENT: INTRODUCE QC TOOLING USED FOR QUALITY INSPECTION PURPOSE IN THE CALIBRATION PROGRAM TO GUARANTEE MEASUREMENT ASSURANCE. 3. MACHINERY / EQUIPMENT/ SOFTWARE INVESTIGATION DIFFERENT MOVEMENT RELATION VS CARDAN IN THE YAMAHA ARM PADS. IF THE COGNEX CAMERAS OF THE VISION SYSTEM IS NOT CLEAN. IN THE VISION SYSTEM, THE MODEL IN THE SYSTEM IS NOT CENTRALIZED. WHEN THE YAMAHA IS NOT ADJUSTED IF THE WEB INDEX IS MOVED, DUE TO THE POSITIONING OF THE VISION SYSTEM. NO ISSUES WERE IDENTIFIED FOR MANPOWER, MEASUREMENT AND ENVIRONMENT INVESTIGATIONS. 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

    IT WAS REPORTED THE STARTER HOLE WAS OFF CENTER IN 10 WAFERS. NO PHOTO PROVIDED.

    Additional Manufacturer Narrative · 1

    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 IN 10 WAFERS. NO PHOTO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649163 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 404592 8G01431

    Patients

    Seq Age Sex Outcome Treatment
    1 Male