BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNITROL AER PLUS 387P

    MDR report key: 127653 · Received October 20, 1997

    Report

    Report Number
    2150060-1997-00008
    Event Type
    Other
    Date Received
    October 20, 1997
    Date of Event
    September 26, 1997
    Report Date
    October 17, 1997
    Manufacturer
    UNITROL DIVISION OF MINNTECH
    Product Code
    MLR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTS A PATIENT WAS EXPOSED TO GLEUTERALDAHYDE. PATIENT HAD BLOODY DIARRHEA AND WAS SEEN BY A PHYSICIAN. PATIENT WAS HOSPITALIZED FOR 2 DAYS AND RELEASED. UNKNOWN IF MEDICATION WAS ADMINISTERED. PATIENT REPORTED TO HAVE NO LONG-TERM EFFECTS FROM INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNITROL AER PLUS 387P ENDOSCOPE REPROCESSOR MLR UNITROL DIVISION OF MINNTECH 387P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization