BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C/HESIVE NAT WFR FLEX 35/45MM (1X5)GB/NL

    MDR report key: 9353428 · Received November 21, 2019

    Report

    Report Number
    9618003-2019-10967
    Event Type
    Malfunction
    Date Received
    November 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

    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. BATCH RECORD REVIEW: LOT 8L04398 WAS MANUFACTURED ON 12/12/2018, LINE CONVEX 2-PIECE (PC) 2, WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 11/18/2020, 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) CODE 125285 SYSTEM APPLICATION PRODUCT (SAP) MATERIAL 1051438 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) 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 QUALITY CONTROL (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. 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 5 OF 5. (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

    THE END USER REPORTED THAT THE WAFER HAD AN OFF-CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146392 C/HESIVE NAT WFR FLEX 35/45MM (1X5)GB/NL PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 125285 8L04398

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown