BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALTON DEAN

    MDR report key: 80159 · Received April 1, 1997

    Report

    Report Number
    80159
    Event Type
    Other
    Date Received
    April 1, 1997
    Date of Event
    March 20, 1997
    Report Date
    March 27, 1997
    Manufacturer
    ALTON DEAN MEDICAL, INC.
    Product Code
    LJH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLADDER PERFORATION OCCURRED DURING TURP POSSIBLY DUE TO IRRIGATION PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTON DEAN AUTOMATIC HIGH PRESSURE SURGICAL IRRIGATION PUMP LJH ALTON DEAN MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other