BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELSOFT

    MDR report key: 8293095 · Received January 31, 2019

    Report

    Report Number
    9612515-2019-00001
    Event Type
    Death
    Date Received
    January 31, 2019
    Date of Event
    December 21, 2018
    Report Date
    March 1, 2019
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881115542
    PMA / PMN Number
    K955230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT CODE: 3221 - NO FINDINGS AVAILABLE - INFORMATION PROVIDED BY THE CUSTOMER WAS NOT SUBSTANTIAL TO CARRY OUT COMPLETE INVESTIGATION. CONCLUSION CODE: 4315 - CAUSE NOT ESTABLISHED. AT VASCUTEK LTD ALL DEVICES ARE SCANNED DURING PACKAGING PROCESS. AFTER DEVICE IS SEALED IN INNER AND OUTER BLISTER IT IS STERILISED AND THEN PASSED THROUGH TO FINAL PACK FOR FURTHER PACKAGING. AT POST STERILISATION STAGE ALL BLISTERS (WITH GRAFTS SEALED INSIDE) ARE INSPECTED FOR ANY CONTAMINATION OR DAMAGE. THEN IT IS PROCESSED THROUGH THE PACKAGING LINE WHERE PRODUCT IS SCANNED AT FOUR STAGES. VASCUTEK LTD RETRIEVED INFORMATION FROM DATABASE THAT SHOWS THAT COMPLAINT DEVICE WAS SCANNED AT ALL STEPS AND THEN SECURELY SEALED BEFORE DESPATCH TO THE CUSTOMER. FROM THE IMAGES PROVIDED BY THE CUSTOMER IT WAS NOTED THAT GLUE RESIDUE IS STILL PRESENT ON THE OUTER BLISTER FROM THE HEAT SEALING STAGE. ON THE IMAGE IT WAS ONLY OUTER BLISTER AND BOX PRESENT, NO OTHER PACKAGING ITEMS WERE PRESENT. CUSTOMER COULD NOT CONFIRM WHAT PACKAGING ITEMS WERE PRESENT WHEN PRODUCT WAS RECEIVED; THEREFORE, VASCUTEK LTD COULD NOT CONFIRM AND FULLY INVESTIGATE THE COMPLAINT. FURTHER ACTION IS NOT PLANNED; HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME. VASCUTEK LTD CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED AS FINAL NARRATIVE FOR MFR. REPORT # 9612515-2019-00001 TO PROVIDE CLOSURE INFORMATION FOR THE CASE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE RETAINED MANUFACTURING AND DATABASE RECORDS CONFIRMED THAT WHOLE BATCH OF 8 GRAFTS WAS SCANNED AT ALL STEPS AT FINAL PACK AND THEN SEALED WITH TAMPER-PROOF LABEL. PRODUCT WAS MANUFACTURED TO SPECIFICATION. THERE WERE NO OTHER COMPLAINTS FOR THE SAME ISSUE FOR OTHER GRAFTS FROM THE SAME BATCH. SIMILAR EVENTS REVIEW SHOWED VERY LOW OCCURRENCE RATE OF <(B)(4) (COMPLAINTS V SALES). ADDITIONAL INFORMATION ON THE EVENT WAS REQUESTED FROM THE CUSTOMER FOR FURTHER EVENT INVESTIGATION. INVESTIGATION RESULTS WILL BE COMMUNICATED IN FOLLOW UP/FINAL REPORT.

    Description of Event or Problem · 1

    VASCUTEK LTD WAS NOTIFIED OF AN EVENT THAT OCCURRED IN (B)(6), THE EVENT WAS DESCRIBED AS FOLLOWS: AT THE (B)(6), THERE WAS NO DEVICE FOUND INSIDE THE BOX. THE REPORT FROM THE HOSPITAL STATES THAT MISSING DEVICE LED TO PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86025 GELSOFT GLESOFT PLUS BIFURCATE DSY VASCUTEK LTD 16991576 0505 05037881115542

    Patients

    Seq Age Sex Outcome Treatment
    1 Death