BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE HANDS-FREE BREASTPUMP

    MDR report key: 6910141 · Received October 3, 2017

    Report

    Report Number
    1419937-2017-00277
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    September 14, 2017
    Report Date
    October 2, 2017
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K150499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TROUBLESHOOTING WAS CONDUCTED WITH THE CUSTOMER, INCLUDING VERIFYING CORRECT BREAST SHIELD FIT; DISASSEMBLING, INSPECTING, CLEANING AND REASSEMBLING THE KIT AND TUBING SET; POWERING THE DEVICE WITH THE POWER SUPPLY; AND RESETTING THE BATTERY AND REQUESTING THAT THE BATTERY.  THE CUSTOMER WAS SENT A REPLACEMENT BREAST PUMP. IN FOLLOW UP WITH MEDELA LLC ON (B)(6) 2017, THE CUSTOMER REPORTED THAT THE REPLACEMENT PUMP WAS WORKING WITHOUT ISSUE, THAT SHE HAS FINISHED THE ANTIBIOTIC AND THE MASTITIS IS RESOLVED.  BASED ON THE RESULTS OF (B)(4), IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S MASTITIS. MASTITIS IS USUALLY A BENIGN, SELF-LIMITING INFECTION WITH FEW CONSEQUENCES FOR THE SUCKLING INFANT.   THE RISK OF MASTITIS IS HIGHER AMONG WOMEN WHO HAVE BREASTFED PREVIOUSLY, ESPECIALLY THOSE WITH A HISTORY OR MASTITIS."  RIORDAN & WAMBACH, 4TH ED. P. 294: BREASTFEEDING AND HUMAN LACTATION. MASTITIS REQUIRES PROMPT MEDICAL ATTENTION FOR THE MOTHER FOR PAIN RELIEF AND PRESCRIPTION ANTIBIOTICS TO AVOID PROGRESSION TO OVERWHELMING SEPSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER FREESTYLE BREAST PUMP. SHE STATED THAT SHE HAD BEEN TO HER DOCTOR AND IS GETTING OVER CLOGGED DUCTS AND MASTITIS. SHE HAS BEEN TAKING AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690540 FREESTYLE HANDS-FREE BREASTPUMP PUMP, BREAST, POWERED HGX MEDELA AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other