BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CDIS UNIT

    MDR report key: 108002 · Received July 24, 1997

    Report

    Report Number
    1526350-1997-00017
    Event Type
    Injury
    Date Received
    July 24, 1997
    Date of Event
    May 19, 1997
    Report Date
    July 16, 1997
    Manufacturer
    ZIMMER PATIENT CARE DIVISION
    Product Code
    HIG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ALLEGEDLY ABSORBED 1200CC'S OF 1.5% GLYCINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CDIS UNIT CONTROLLED DISTENTION IRRIGATION SYSTEM HIG ZIMMER PATIENT CARE DIVISION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention