BEUDAMED
    FDA Adverse Event Summary report: N

    DISPOSABLE MYR BLADE WITH HANDLE

    MDR report key: 5150802 · Received October 14, 2015

    Report

    Report Number
    1037007-2015-00007
    Date Received
    October 14, 2015
    Date of Event
    August 20, 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. CAP-(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
    680796 DISPOSABLE MYR BLADE WITH HANDLE BLADE LRC GYRUS ACMI, INC. 70130791 SD954316

    Patients

    Seq Age Sex Outcome Treatment
    1