BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3O0200 - NATURA

    MDR report key: 14133397 · Received April 18, 2022

    Report

    Report Number
    9618003-2022-00301
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Report Date
    March 21, 2022
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455187041
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 1 OF 3. 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 (B)(4).

    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. BATCH RECORD REVIEW: LOT 1F04730 WAS MANUFACTURED ON 08/JUN/2021, IN ATS #2 LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). COMPLIANCE ENGINEER PERFORMED A BATCH RECORD REVIEW ON 29/MAR/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 ID 1222278 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE WERE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. CONCLUSION SUMMARY OF THE RELATED EVENT: DURING THE EVENT SUMMARY AND IMPACT EVALUATION OF THIS NONCONFORMANCE REPORT (NCR), WITH THE SUPPORT OF THE TRIAGE TEAM EXPERTISE, THE MOST PROBABLE CAUSES OF THE PROBLEM IDENTIFIED: METHOD ¿ PICK AND PLACE VACUUM NIPS NOT STANDARDIZED. THE APPROPRIATE ACTIONS WILL BE TAKEN THROUGH THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPAS). THE INVESTIGATION ASSOCIATED WITH RELATED EVENT RECORD HAS BEEN APPROVED AND WAS 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 SHE TOOK HER WAFERS TO HER OSTOMY NURSE BECAUSE SHE WAS HAVING TROUBLE WITH THE ADHESIVE STICKING. SHE STATED THAT THE NURSE NOTED THE STARTER HOLES WERE OFF-CENTERED. THE PHOTOGRAPHS OBTAINED BY THE NURSE DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    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
    140408 L3O0200 - NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411804 1F04730 00768455187041

    Patients

    Seq Age Sex Outcome Treatment
    1 Female