BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDINAL OCTYL

    MDR report key: 8700661 · Received June 14, 2019

    Report

    Report Number
    9617175-2019-00009
    Event Type
    Death
    Date Received
    June 14, 2019
    Report Date
    August 2, 2019
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LIMITED
    Product Code
    MPN
    PMA / PMN Number
    K132243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FIRST COMPLAINT THAT AMS HAS RECEIVED OF THIS NATURE. A FULL TRACE OF ASSOCIATED BATCH RECORDS WAS CONDUCTED WITH NO ANOMALIES OR RELEVANT OBSERVATIONS. ALL STERILITY PROCESSING AND PRODUCT TEST RELEASE WAS TO SPECIFICATION. NO APPARENT LINK CAN BE DETERMINED TO ASSOCIATE THE PRODUCT TO THE EVENT. MULTIPLE, DOCUMENTED ATTEMPTS HAVE BEEN MADE TO GAIN FURTHER INFORMATION INTO THIS EVENT WITH NO SUCCESS. IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DEATH OCCURRED, EVENTS HAPPENED AFTER DISCHARGE AND WOULD BE FEW DAYS TO WEEK AFTER PROCEDURE.

    Additional Manufacturer Narrative · 1

    INSUFFICIENT INFORMATION PROVIDED AND AT THIS TIME WE ARE UNABLE TO CONFIRM IF THE DEVICE CAUSED OR CONTRIBUTED TO DEATH. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DEATH OCCURRED, EVENTS HAPPENED AFTER DISCHARGE AND WOULD BE FEW DAYS TO WEEK AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493158 CARDINAL OCTYL TOPICAL SKIN ADHESIVE MPN ADVANCED MEDICAL SOLUTIONS LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Death