BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS

    MDR report key: 5240541 · Received November 20, 2015

    Report

    Report Number
    3009974348-2015-00181
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    September 1, 2015
    Report Date
    October 26, 2015
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SHIPPED A REPLACEMENT PURELY YOURS BREAST PUMP ON (B)(6) 2015. THE CUSTOMER WAS INSTRUCTED TO RETURN THE PURELY YOURS BREAST PUMP TO AMEDA, INC FOR INVESTIGATION. THE CUSTOMER WAS PHONED TWICE AND EMAILED ONCE REQUESTING PRODUCT RETURN. AS OF THIS DATE, THE PUMP HAS NOT BEEN RETURNED TO AMEDA, INC. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PUMP IS RETURNED TO AMEDA.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2015 TO REPORT THE PURELY YOURS BREAST PUMP SHE BEGAN USING AFTER BABY WAS READMITTED TO THE HOSPITAL IN (B)(6) 2015 DID NOT EXPRESS HER MILK SUFFICIENTLY. BREASTS WERE LEFT FULL AND CLOGGED DUCTS DEVELOPED. THIS RESULTED IN RIGHT BREAST MASTITIS WHICH WAS DIAGNOSED BY HER HEALTHCARE PROVIDER IN (B)(6) 2015. MASTITIS RESOLVED QUICKLY ONCE CUSTOMER (MOTHER) BEGAN ROOMING IN WITH HER BABY AT THE HOSPITAL SO BABY COULD NURSE FREQUENTLY. SHE USED A HOSPITAL GRADE BREAST PUMP AND WAS PRESCRIBED ORAL ANTIBIOTICS TO RESOLVE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771056 PURELY YOURS ELECTRIC BREAST PUMP HGX AMEDA, INC. 24502082

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other