BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOUGIE ESOPHAGEAL DILATOR

    MDR report key: 76609 · Received March 18, 1997

    Report

    Report Number
    76609
    Event Type
    Other
    Date Received
    March 18, 1997
    Date of Event
    February 28, 1997
    Report Date
    March 14, 1997
    Manufacturer
    MEDOVATIONS, INC.
    Product Code
    KNQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING VERTICAL BANDING GASTROPLASTY. MERCURY FILLED BOUGIL ESOPHAGEAL DILATOR INSERTED THROUGH SURGEON. SURGEON PUNCTURED THE DIALATOR DURING THE STAPLING PROCESS, CAUSING MERCURY TO LEAK FROM THE DILATOR INTO THE PT. LEAK NOTICED WHEN DILATOR REMOVED. MERCURY ALSO LEAKED ONTO SURGICAL TOWELS AND FLOOR. MERCURY SPILL KIT USED TO RECOVER THE MERCURY. UNRECOVERED MERCURY EQUALED 0.018 LBS. UNKNOWN QUANTITY REMAINED IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOUGIE ESOPHAGEAL DILATOR MERCURY FILLED ESOPHAGEAL DILATOR KNQ MEDOVATIONS, INC. 11-597 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other