BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS ULTRA

    MDR report key: 5375638 · Received January 18, 2016

    Report

    Report Number
    3009974348-2016-00189
    Event Type
    Injury
    Date Received
    January 18, 2016
    Date of Event
    December 16, 2016
    Report Date
    December 21, 2016
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS EVALUATED FOR EVIDENCE OF ALLEGATION. THE RETURNED AMEDA PURELY YOURS BREAST PUMP MET AMEDA SPECIFICATIONS FOR BOTH SUCTION AND SPEED, AND PASSED VISUAL INSPECTION STANDARDS. NO EVIDENCE OF MALFUNCTION WAS OBSERVED. RETURNED PUMP PASSED ALL FUNCTIONAL TESTING.

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS CONTACTED FOUR TIMES VIA EMAIL AND PHONE, REQUESTING RETURN OF THE BREAST PUMP TO AMEDA, INC. FOR INVESTIGATION. CUSTOMER RESPONDED, STATING SHE HAD A DEATH IN HER IMMEDIATE FAMILY AND WILL RETURN THE PUMP SOON. AS OF THIS DATE, PRODUCT HAS NOT BEEN RETURNED, THEREFORE NO VISUAL INSPECTION OR TESTING WAS PERFORMED ON THE PRODUCT. IF PRODUCT IS RETURNED TO AMEDA, INC., A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2015 BY EMAIL, REPORTING THE PURELY YOURS ULTRA BREAST PUMP BEGAN HAVING AN ISSUE WITH LOW SUCTION ON BOTH SIDES WHEN DUAL PUMPING, WITH THE LEFT SIDE HAVING LOWER SUCTION THAN THE RIGHT. CUSTOMER CONDUCTED SOME TROUBLESHOOTING ON HER OWN BY REPLACING PUMP PARTS WHICH DID NOT RESOLVE THE LOW SUCTION. CUSTOMER REPORTS LOW SUCTION LED TO DECREASED MILK OUTPUT, CLOGGED MILK DUCTS AND A DIAGNOSIS OF LEFT BREAST MASTITIS. CUSTOMER WAS PRESCRIBED A 10 DAY COURSE OF ORAL ANTIBIOTICS BY HER HEALTHCARE PROVIDER ON (B)(6) 2015. MASTITIS RESOLVED WITHIN 2 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33415 PURELY YOURS ULTRA ELECTRIC BREAST PUMP HGX AMEDA, INC. 24501879

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other