BEUDAMED
    FDA Adverse Event Other Summary report: N

    HAWKINS III BLN

    MDR report key: 1053565 · Received May 29, 2008

    Report

    Report Number
    1036710-2008-00005
    Event Type
    Other
    Date Received
    May 29, 2008
    Date of Event
    March 31, 2008
    Report Date
    May 6, 2008
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Product Code
    MIJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS DUE TO SEALING ISSUES ISOLATED TO THIS SPECIFIC LOT NUMBER. RECALL ISSUED DUE TO POSSIBLE STERILITY IMPACT. NO ADVERSE EVENT OCCURRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PACKAGES WERE OPENED. INITIAL REVIEW OF THE COMPLAINT DID NOT DETERMINE THIS WAS A SAFETY ISSUE OR A REPORTABLE EVENT. ON APRIL 28, 2008 THE SAMPLES WERE RETURNED BY THE CUSTOMER. WE ARE UNABLE TO ISOLATE THE PROBLEM TO THE SAMPLES INVOLVED IN THE COMPLAINT, BUT WE ARE ABLE TO ISOLATE THE PROBLEM LOT TO WHICH THE SAMPLES BELONG. BASED ON THE RETURNED SAMPLES AND FURTHER INVESTIGATION RESULTS, MEDICAL DEVICE TECHNOLOGIES, INC HAS DECIDED TO IMPLEMENT A FIELD CORRECTIVE ACTION. FDA NOTIFICATION OF ACTION WAS SENT ON MAY 6, 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAWKINS III BLN BREAST LOCALIZATION NEEDLE MIJ MEDICAL DEVICE TECHNOLOGIES, INC. 80281L5V

    Patients

    Seq Age Sex Outcome Treatment
    1