BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUASONIC 100 ULTRASOUND TRANSMISSION GEL

    MDR report key: 1507908 · Received October 2, 2009

    Report

    Report Number
    2212018-2009-00001
    Event Type
    Injury
    Date Received
    October 2, 2009
    Date of Event
    January 1, 2005
    Report Date
    September 21, 2009
    Manufacturer
    PARKER LABORATORIES, INC.
    Product Code
    MUI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG#'S 01-08, 01-50. VOLUNTARY MEDWATCH REPORT REC'D FROM FDA ON 09/21/09. EVENT DATE INDICATED WAS 2005. NO REPORT HAD BEEN REC'D AT THAT TIME BY THE MFR. ONLY ONE OTHER REPORT OF A SIMILAR NATURE HAS BEEN REC'D IN OVER FIVE YEARS. THE PT HAS A KNOWN ALLERGY TO METHYLPARABEN. THE IDENTIFICATION OF THE PRESERVATIVES IN AQUASONIC 100 IS DOCUMENTED ON THE PRODUCT TECHNICAL DATA SHEET THAT IS READILY AVAILABLE UPON REQUEST.

    Description of Event or Problem · 1

    PT REPORTED TO FDA THROUGH THE MEDWATCH PROGRAM THAT ON TWO SEPARATE OCCASIONS, A SEVERE ANGIOEDEMA REACTION OCCURRED AFTER ULTRASOUND PROCEDURES USING AQUASONIC 100, REQUIRING ORAL STEROIDS, INHALED STEROIDS, NEBULIZED ALBUTEROL, AND H1 AND H2 ANTIHISTAMINES. PT IS ALLERGIC TO METHYLPARABEN AND BELIEVES THAT INGREDIENTS SHOULD HAVE BEEN LISTED ON THE LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUASONIC 100 ULTRASOUND TRANSMISSION GEL ULTRASOUND COUPLING MEDIA MUI PARKER LABORATORIES, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention