BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 110499 · Received August 1, 1997

    Report

    Report Number
    MW1011814
    Event Type
    Malfunction
    Date Received
    August 1, 1997
    Report Date
    August 1, 1997
    Manufacturer
    UNK
    Product Code
    EAJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS RESPONSE WAS SENT TO THE PURCHASING COMPANY AS WELL AS THE STATE RADIATION REGULATORY AGENCY. THIS FOLLOWED THE ALERT OF POSSIBLE CONTAMINATION OF RADIATION SHEILDING DEVICES WHICH WAS RECEIVED IN JUNE, 1997. ON JUNE 23, 1997, A LETTER ARRIVED FROM THE DEP WHICH ALERTED ALL RECIPIENTS TO AN IMPENDING LEAD APRON RECALL. IT WAS ASCERTAINED THAT THIS DEPT WAS IN RECEIPT OF SHIELDING DEVICES MFG DURING THE TIME PERIOD SPECIFIED. THE SHIELDING DEVICES WERE REMOVED FROM USE THAT SAME DAY AND TESTED BY THE FACILITY IN THE FOLLOWING FASHION: AN ABERLINE GM SURVEY METER WAS UTILIZED; BACKGROUND RADIATION WAS CALCULATED AT .02 MR/HR, SETTING WAS .01 WITH AN OPEN WINDOW. 2 REGULAR LENGTH AND 1 HALF-LENGTH SHIELD READINGS RANGED FROM .1---.15 MR/HR AT THE SURFACE AND .05 MR/HR AT A DISTANCE OF 3 FEET. ALL THREE DEVICES WERE ISOLATED IN THE "HOT LAB" STORAGE AREA OF THE NUCLEAR MEDICINE DEPT AS FURTHER INSTRUCTIONS CONCERNING THEIR RETURN WERE AWAITED. ON JULY 11, 1997, THE DEVICES WERE RETRIEVED BY A REP OF THE DISTRIBUTOR AND RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK LEAD APRON EAJ UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *