BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS ULTRA

    MDR report key: 5006602 · Received August 11, 2015

    Report

    Report Number
    3009974348-2015-00164
    Event Type
    Injury
    Date Received
    August 11, 2015
    Date of Event
    January 1, 2014
    Report Date
    April 25, 2014
    Manufacturer
    AMEDA INC.
    Product Code
    HGX
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, CUSTOMER HAS NOT RETURNED THE PURELY YOURS ULTRA BREAST PUMP TO AMEDA AS REQUESTED. THEREFORE A VISUAL INSPECTION AND INVESTIGATION COULD NOT BE COMPLETED.

    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. CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2014 TO REPORT THE PURELY YOURS ULTRA BREAST PUMP SHE USES DEVELOPED LOW SUCTION IN (B)(6) 2014 WHEN HER BABY STOPPED BREASTFEEDING. THE PUMP'S LOW SUCTION RESULTED IN DECREASED MILK OUTPUT. CUSTOMER REPLACED MANY PUMP PIECES WHICH DID NOT RESOLVE THE SUCTION ISSUE. CUSTOMER WAS DIAGNOSED WITH MASTITIS IN MID (B)(6) 2014 AFTER CONTACTING HER HEALTH CARE PROVIDER AND WAS PRESCRIBED ORAL ANTIBIOTICS TO RESOLVE INFECTION. CUSTOMER DID NOT RESPOND WELL TO THE FIRST ANTIBIOTIC SO WAS PRESCRIBED A DIFFERENT ORAL ANTIBIOTIC TO TREAT THE INFECTION. CUSTOMER WAS HOSPITALIZED BY MID (B)(6) 2014 FOR A DIAGNOSIS OF BREAST ABSCESS. SHE WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND THE ABSCESS WAS INCISED AND DRAINED. CUSTOMER RENTED A HOSPITAL GRADE BREAST PUMP TO MAINTAIN MILK SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526716 PURELY YOURS ULTRA ELECTRIC BREAST PUMP HGX AMEDA INC. 24501879

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O