BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIS SABER ATTACHMENT

    MDR report key: 2803037 · Received October 17, 2012

    Report

    Report Number
    1811755-2012-03850
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 18, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT SOME BLACK POWDER WAS OBSERVED INSIDE THE ATTACHMENT. THE CUSTOMER CLAIMED THAT INFECTIONS WERE NOTED WHEN THE DEVICE WAS USED. FURTHER COMMUNICATION WITH THE CUSTOMER IS ANTICIPATED. THERE WAS NO REPORTED MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIS SABER ATTACHMENT ERL STRYKER INSTRUMENTS KALAMAZOO 09205

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK