BEUDAMED
    FDA Adverse Event Summary report: N

    DISPOSABLE MYR BLADE WITH HANDLE

    MDR report key: 5150812 · Received October 14, 2015

    Report

    Report Number
    1037007-2015-00009
    Date Received
    October 14, 2015
    Date of Event
    September 17, 2015
    Report Date
    January 26, 2016
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    LRC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT OF AN UNSEAL POUCH WAS CONFIRMED. THE RETURNED PRODUCT WAS REVIEWED AND FOUND THAT 100% OF THE LOT WAS UNSEALED WITH NO VISIBLE INDICATIONS THAT THE PRODUCT HAD BEEN RUN THROUGH THE SEALER. (B)(4) HAS BEEN INITIATED TO FURTHER INVESTIGATE INTO THE ROOT CAUSE OF THE ISSUE. A REVIEW OF THE DISTRIBUTION DATA FOR THE AFFECTED ITEM AND LOT FOUND THAT NO AFFECTED PRODUCT SHIPPED TO CUSTOMERS IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME PACKAGES WERE FOUND UNSEALED AT ONE END.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME PACKAGES WERE FOUND UNSEALED AT ONE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680864 DISPOSABLE MYR BLADE WITH HANDLE BLADE LRC GYRUS ACMI, INC. 70130791 SD954316

    Patients

    Seq Age Sex Outcome Treatment
    1