BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS ULTRA

    MDR report key: 4871823 · Received June 17, 2015

    Report

    Report Number
    3009974348-2015-00123
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    February 25, 2014
    Report Date
    February 27, 2014
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    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.

    Description of Event or Problem · 1

    AS PART OF AMEDA, INC'S QUALITY MANAGEMENT SYSTEM ACTIVITIES, A REVIEW OF HISTORICAL COMPLAINTS WAS CONDUCTED. IT WAS DETERMINED THAT THIS COMPLAINT SHOULD HAVE BEEN REPORTED TO FDA. CUSTOMER CONTACTED AMEDA, INC. ON (B)(4) 2014 TO REPORT THE PURELY YOURS ULTRA BREAST PUMP SHE USES HAS LOW SUCTION AND SHE IS UNABLE TO EXPRESS BREAST MILK EFFECTIVELY. CUSTOMER REPORTS DEVELOPING SORE NIPPLES BECAUSE SHE USED AN INCORRECT FLANGE SIZE. CUSTOMER STATES DEVELOPING MASTITIS WHICH SHE SOUGHT MEDICAL TREATMENT FOR. CUSTOMER WAS TREATED WITH A 10 DAY COURSE OF ORAL ANTIBIOTICS AND RENTED A MULTI-USER BREAST PUMP TO EXPRESS HER MILK UNTIL SHE HEALED COMPLETELY FROM THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394283 PURELY YOURS ULTRA ELECTRIC BREAST PUMP, 884.5160 HGX AMEDA, INC. 24501879

    Patients

    Seq Age Sex Outcome Treatment
    1 Other