BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURA

    MDR report key: 8655354 · Received May 30, 2019

    Report

    Report Number
    9618003-2019-03795
    Event Type
    Injury
    Date Received
    May 30, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED SAMPLE EVALUATION: NO PHOTOGRAPH ASSOCIATED WITH THIS CASE AND NO UNUSED RETURN SAMPLE WAS EXPECTED. BATCH RECORD REVIEW: LOT 8K02315 WAS MANUFACTURED ON 11/01/2018, IN THE CONVEX 2 PC (OST) LINE WITH A TOTAL OF 5,760 MKU. COMPLIANCE ENGINEER ID 6053 PERFORMED A BATCH RECORD REVIEW ON (B)(6) 2021, TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND. ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BOM, UNDER ICC CODE 413180, SAP MATERIAL ID 1161269 AND MANUFACTURING ORDER 1431807. THE CREW REQUIREMENTS AND RESPONSIBILITIES, PROCESS PARAMETERS, QUALITY AND IN-PROCESS INSPECTIONS, LINE OPERATIONS, PROCESS TROUBLESHOOTING AND RELEVANT DOCUMENTS TO THE PROCESS WERE RUN ACCORDING THE PROCESS INSTRUCTION PI21-108. THE PROCESS REQUIREMENTS RESULTS WERE DOCUMENTED IN THE MANUFACTURING RECORDS MR21-108. BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. CONCLUSION SUMMARY OF THE RELATED EVENT: MATERIAL, METHOD/PROCESS, MANPOWER AND MEASUREMENT SECTIONS WERE REVIEWED, AND IT IS CONSIDERED NONE OF THEM INTERFERED ON THE INCIDENCE OF THE ROOT CAUSE, ALSO, THESE SECTIONS AND POSSIBLE OPPORTUNITIES WERE PREVIOUSLY COVERED UNDER TW# (B)(4). BASED ON THE INVESTIGATION FINDINGS THROUGH REVISION OF THE BATCH RECORDS DOCUMENTATION, PROCESS OBSERVATION, PERSONNEL INTERVIEWED, METHODOLOGY IMPLEMENTED, THE ROOT CAUSE FOR THIS FAILURE MODE WAS IDENTIFIED AS MACHINE. AS OBSERVED DURING THIS INVESTIGATION THE CONTRIBUTOR FACTORS TO THIS FAILURE MODE WERE THE FOLLOWING: A) CONDITION OF THE YAMAHA ARM. B) CONDITION OF VISION SYSTEM CAMERAS. C) VARIANCE IN THE MATERIALS, CAUSE VARIATION IN THE PLACEMENT. THIS IS CAUSING THE OVERALL VARIATION 0.6. THIS ACCUMULATION OF VARIATION CAUSES THE COMPLAINT IN SECTION 1. TO MAINTAIN ACCEPTABLE LEVELS OF VARIATION THE MAINTENANCE FOR THE ARM WILL BE IMPROVED. AND BASE ON THE RATE OF COMPLAINTS AND THE VARIATION IDENTIFY, CODES WITH A RATE HIGHER THAN 10 COMPLAINTS PER MILLION WILL BE BLOCK AND MANUFACTURED ON THE IMPROVE CONVEX 2 PC IN BUILDING 8A. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. THIRD PARTY MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. 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

    END USER REPORTED APPROXIMATELY TWO (2) WEEKS AGO "STOOL WAS LEAKING NEAR THE RIGHT SIDE OF HER STOMA. SHE VISITED HER LOCAL WOUND OSTOMY NURSE WHO ADVISED THAT HER WAFER OPENING WAS TOO SMALL DUE TO HER OVAL-SHAPED STOMA AND HAD CAUSED A LACERATION IN THE STOMA"; "IT WAS SMALL, LIKE A "PIN-PRICK" AND THE WOUND OSTOMY NURSE BELIEVES IT WILL HEAL ON ITS OWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449181 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 413180 8K02315

    Patients

    Seq Age Sex Outcome Treatment
    1