BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURELY YOURS ULTRA

    MDR report key: 6812079 · Received August 22, 2017

    Report

    Report Number
    3009974348-2017-00284
    Event Type
    Injury
    Date Received
    August 22, 2017
    Date of Event
    July 24, 2017
    Report Date
    July 26, 2017
    Manufacturer
    AMEDA, INC.
    Product Code
    HGX
    UDI-DI
    00810725021484
    PMA / PMN Number
    K973501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS CONTACTED MULTIPLE TIMES REQUESTING THE PURELY YOURS ULTRA PUMP RETURN FOR INVESTIGATION OF ALLEGATION FOR LOW SUCTION. SHE HAS NOT RETURNED THE PUMP BASE THEREFORE NO VISUAL EXAMINATION OR IN-DEPTH TESTING COULD BE PERFORMED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED WITH THE FDA IF THE PRODUCT IS RETURNED TO AMEDA, INC. AT A LATER DATE.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS EVALUATED FOR EVIDENCE OF ALLEGATION. THE RETURNED (B)(4) BREAST PUMP HAS NOT MET (B)(4) SPECIFICATIONS FOR BOTH SUCTION AND SPEED, AND PASSED VISUAL INSPECTION STANDARDS. THERE WAS A EVIDENCE OF MALFUNCTION OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2017 TO REPORT THE PURELY YOURS ULTRA BREAST PUMP SHE USES TO EXCLUSIVELY PUMP HER BREAST MILK FOR HER BABY HAS NOT BEEN WORKING PROPERLY FOR THE PAST 2 WEEKS. SHE STATES HER BREASTS ARE NOT DRAINING AS WELL AND THEREFORE MILK OUTPUT IS LOWER. SHE DESCRIBES THE PUMP BEGINS WITH PROPER SUCTION THEN AFTER 2-4 MINUTES, SUCTION PRESSURE SUDDENLY DECREASES ON ITS OWN ACCORD. ON (B)(6) 2017, CUSTOMER WAS EXAMINED BY HER PHYSICIAN FOR A SORE, SWOLLEN OUTER AREA IN HER LEFT BREAST. THE PHYSICIAN DIAGNOSED HER WITH LEFT BREAST MASTITIS AND PRESCRIBED A 10 DAY COURSE OF ORAL ANTIBIOTICS. CUSTOMER REPORTS FEELING IMPROVEMENT AFTER 2 DAYS OF TAKING THE MEDICATION. PURELY YOURS BREAST PUMP BASE WAS REPLACED FOR THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590512 PURELY YOURS ULTRA ELECTRIC BREAST PUMP HGX AMEDA, INC. 24501879 00810725021484

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other