BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUA EEZ

    MDR report key: 448165 · Received March 7, 2003

    Report

    Report Number
    2434117-2003-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2003
    Date of Event
    January 25, 2003
    Report Date
    February 4, 2003
    Manufacturer
    AQUA EEZ, INC.
    Product Code
    ILJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN BIRTHING TUB, IN ACTIVE PHASE, INFANT HAD SHOULDER DYSTOCIA. TUB FAILED TO DRAIN ACCORDING TO MANUFACTURE GUIDELINES. PT REMOVED FROM BIRTHING TUB TO COMPLETE DELIVERY, SHOULDER DYSTOCIA NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUA EEZ BIRTHING TUB ILJ AQUA EEZ, INC. 3020 *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other