BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYGIENIKIT

    MDR report key: 4101601 · Received August 27, 2014

    Report

    Report Number
    3009974348-2014-00027
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    July 31, 2014
    Report Date
    July 31, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGY
    PMA / PMN Number
    K011519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS BEEN UNDER THE CARE OF A LACTATION CONSULTANT AND HAS BEEN USING A CORTISONE CREAM AND LANOLIN PREPARATION TO MANAGE HER SYMPTOMS. THE CUSTOMER HAS DECLINED AN OFFER TO SPEAK WITH AMEDA'S LACTATION CONSULTANT. THREE VOICE MAIL MESSAGES WERE LEFT WITH THE CUSTOMER TO FURTHER ASSESS HER RASH AND ONE VOICE MESSAGE LEFT FURTHER ASSESS HER RASH AND ONE VOICE MESSAGE LEFT ASKING CUSTOMER TO PROVIDE THE FLANGE LOT NUMBER, LOCATED ON PACKAGE INSERT. TO DATE, THE CUSTOMER HAS NOT RETURNED THE CALLS. NO PRODUCT RETURN IS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED AMEDA ON (B)(6) 2014 VIA PHONE CALL. SHE STATED THAT SHE DEVELOPED A RED RASH WHEN USING THE HYGIENIKIT FLANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522607 HYGIENIKIT PUMP, BREAST NON-POWERED HGY AMEDA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other