BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDCO/TARACORP

    MDR report key: 108162 · Received July 22, 1997

    Report

    Report Number
    108162
    Event Type
    Injury
    Date Received
    July 22, 1997
    Date of Event
    June 23, 1997
    Report Date
    July 18, 1997
    Manufacturer
    PEAK INTERNATIONAL
    Product Code
    EAJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON RECEIPT OF A LETTER FROM THE CO RE: IMPENDING LEAD APRON RECALL, DEVICES MFG DURING THE TIME PERIOD SPECIFIED WERE REMOVED FROM USE AND TESTED PER THE RECOMMENDED SURVEY METHOD. THE THREE DESIGNATED DEVICES WERE ISOLATED IN "HOT LAB" STORAGE AND RETRIEVED BY MIRA/IMCO (SUPPLIER) ON 7/9/97. MIRA/IMCO RETURNED DEVICES TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDCO/TARACORP Implant LEAD APRON SHIELDING DEVICES EAJ PEAK INTERNATIONAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention