BEUDAMED
    FDA Adverse Event Summary report: N

    HARPER

    MDR report key: 526511 · Received April 28, 2004

    Report

    Report Number
    MW4003710
    Date Received
    April 28, 2004
    Report Date
    March 12, 2004
    Manufacturer
    WATERBIRTH INTERNATIONAL
    Product Code
    ILJ
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT, WHO WISHED TO REMAIN ANONYMOUS, BELIEVES THIS PRODUCT SHOULD BE CLASSIFIED AS A POWERED BATH, CLASS 2 890.5100. THEY DO NOT BELIEVE THE MANUFACTURER HAS A 510K APPROVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARPER BIRTH POOL ILJ WATERBIRTH INTERNATIONAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *