BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 16894331 · Received May 9, 2023

    Report

    Report Number
    9618003-2023-00532
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Report Date
    April 17, 2023
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455187041
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 4 OF 8. 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: 9618003.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6 - INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS H10: INVESTIGATION SUMMARY BATCH RECORD REVIEW: LOT 2M00001 WAS MANUFACTURED ON 02/DEC/2022, IN ATS #2 LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). COMPLIANCE ENGINEER PERFORMED A BATCH RECORD REVIEW ON 15/JUN/2023, 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, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL IDENTIFICATION (ID) 1222278 AND MANUFACTURING ORDER (B)(4). THEREFORE, NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPHS ASSOCIATED WITH THIS CASE WERE RECEIVED AND NO UNUSED RETURN SAMPLE WAS EXPECTED. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED ON THE REVISION OF THE OBSERVATION OF THE PROCESSES INVOLVED, INTERVIEWS TO THE PERSONNEL OF THE LINE AND THE EXPERTISE OF THE TRIAGE TEAM, THIS FAILURE MODE WAS ATTRIBUTED TO THE FOLLOWING PROBABLE CAUSES: ¿ METHOD ¿ PICK AND PLACE VACUUM NIPS NOT STANDARDIZED. THE APPROPRIATE ACTIONS WILL BE TAKEN THROUGH THE CORRECTIVE/PREVENTATIVE ACTION (CAPA) RECORD IN DATABASE. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT RECORD 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

    THE END USER REPORTED THAT THE STARTER HOLE OF EIGHT MOLDABLE WAFERS WERE SIGNIFICANTLY OFF CENTERED FROM ONE MARKET UNIT (MU) FOR KNOWN LOT. HE FELT THAT THIS MADE THE WAFER UNUSABLE. IT WAS OBSERVED PRIOR TO USE AND THE END USER DID NOT USED THE PRODUCTS. ALSO, THE END USER REPORTED THAT THE ISSUE WAS FIRSTLY NOTICED APPROXIMATELY FIVE MONTHS AGO. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

    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
    581978 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411804 2M00001 00768455187041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown