BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONOLITH 3000

    MDR report key: 12308 · Received March 28, 1994

    Report

    Report Number
    MW1001232
    Event Type
    Other
    Date Received
    March 28, 1994
    Date of Event
    July 1, 1989
    Report Date
    March 16, 1994
    Manufacturer
    TECHNOMED INTL., INC.
    Product Code
    FEO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT BILIARY LITHOTRIPSY WITH MARGINAL RESULTS. SHE EVENTUALLY REQUIRED CHOLECYSTECTOMY. SHE WAS SUBSEQUENTLY FOUND TO HAVE A PANCREATIC NEOPLASM. RPTR ASKS IF THE LITHOTRIPSY COULD BE RELATED TO THE PANCREATIC CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONOLITH 3000 BILIARY LITHOTRIPSER FEO TECHNOMED INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other