BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IEHL LITHOTRIPTER

    MDR report key: 12405 · Received March 30, 1994

    Report

    Report Number
    MW1001327
    Event Type
    Injury
    Date Received
    March 30, 1994
    Date of Event
    March 22, 1994
    Report Date
    March 28, 1994
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC.
    Product Code
    MET
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN MENTIONED "DIFFICULTY" WITH LITHOTRIPTER UNIT. DURING PROCEDURE, PT SUSTAINED PERFORATION TO URETER. BECAUSE OF DELAY IN REPORTING OF INCIDENT, PROBE HAD BEEN DISCARDED. BIO MED DEPT TESTED ANOTHER UNIT ON HAND ACCORDING TO MFG SPECIFICATIONS WITHOUT EVIDENCE OF MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IEHL LITHOTRIPTER LITHOTRIPTER MET NORTHGATE TECHNOLOGIES, INC. SD-100

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R