BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    "EGG BUR, MEDIUM"

    MDR report key: 1587066 · Received January 8, 2010

    Report

    Report Number
    9616696-2010-00025
    Event Type
    Malfunction
    Date Received
    January 8, 2010
    Date of Event
    September 26, 2007
    Report Date
    September 27, 2007
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE TWO PART NUMBERS ASSOCIATED WITH THIS COMPLAINT (I.E. PART NO. 5120015050 AND PART NO. 5120010040). THE PRODUCTS WERE NOT RETURNED FOR EVALUATION. BASED ON THE INFO PROVIDED BY THE CUSTOMER, IT CAN BE ASSUMED THAT PRODUCT PACKAGING ASSOCIATED WITH THIS EVENT IS DAMAGED. HOWEVER, STERILITY TESTING COMPLETED ON A SAMPLE OF PRODUCT WITH SIMILAR EVENT DESCRIPTIONS REPORTED HAS DETERMINED THAT THE STERILE BARRIER OF PRODUCT HAS NOT BEEN COMPROMISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEEL AWAY PACKAGING WAS DEFECTIVE. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "EGG BUR, MEDIUM" SURGICAL BURS, DRILLS TREPHINES & ACCESSORIES HBE STRYKER IRELAND LTD. 06128017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK