BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 8723750 · Received June 21, 2019

    Report

    Report Number
    9618003-2019-04551
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    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: BATCH RECORD REVIEW: LOT 8D02136 WAS MANUFACTURED ON 04/18/2018, LINE CONVEX 2 PC 2 WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 08/04/2020, 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, UNDER INTERNATIONAL COMMODITY CODE (ICC) 404593 SYSTEM APPLICATION PRODUCT (SAP) MATERIAL 1175794 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 EVIDENCE AND EXPERTISE, AS CONTRIBUTOR FACTORS FOR THIS EVENT AND, ONE (01) OPPORTUNITY 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. 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 HAVE 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 BY THE END USER THAT 2 PRODUCTS HAD "OFF CENTER STARTER HOLE". THE PRODUCTS WERE NOT USED, NO HARM REPORTED BY THE END USER. NO PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518244 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 404593 8D02136

    Patients

    Seq Age Sex Outcome Treatment
    1 Female