BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8063593

    MDR report key: 8063593 · Received November 13, 2018

    Report

    Report Number
    8063593
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    November 6, 2018
    Report Date
    November 8, 2018
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FOLEY CAME OUT OF PATIENT. WHEN FOLEY CAME OUT BALLOON WAS ALREADY DEFLATED. PATIENT DID NOT EXPERIENCE DISTRESS DURING THIS EVENT.

    Patients

    Seq Age Sex Outcome Treatment
    1 8760 DA