BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALONEY TAPERED MERCURY FILLED

    MDR report key: 227792 · Received June 2, 1999

    Report

    Report Number
    227792
    Event Type
    Malfunction
    Date Received
    June 2, 1999
    Date of Event
    May 27, 1999
    Report Date
    June 2, 1999
    Manufacturer
    PILLING CO.
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGICAL TECH WAS UNWRAPPING ESOPHAGEAL DILATORS WHEN MERCURY SPILLED OUT OF STERILE PACKAGING RESULTING IN HAZARDOUS MATERIAL EXPOSURE TO THE PT AND STAFF. TWO DILATORS FOUND TO HAVE DISLODGED CAPS ALLOWING MERCURY TO SPILL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALONEY TAPERED MERCURY FILLED ESOPHAGEAL BOUGIES KNQ PILLING CO. * *
    2 MALONEY TAPERED MERCURY FILLED ESOPHAGEAL BOUGIES KNQ PILLING CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other