BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWING BREAST PUMP

    MDR report key: 2930710 · Received January 24, 2013

    Report

    Report Number
    1419937-2013-00045
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    MEDELA, AG
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S ISSUE WAS RESOLVED AND PUMP WAS WORKING WELL AFTER TROUBLESHOOTING OVER THE PHONE. ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER TO GET ADDITIONAL COMPLAINT INFORMATION, INCLUDING MEDICAL TREATMENT RECEIVED, IF ANY, WERE UNSUCCESSFUL AND ARE STILL ONGOING. "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 BREAST-FED PREVIOUSLY, ESPECIALLY THOSE WITH A HISTORY OF MASTITIS." ["BREASTFEEDING AND HUMAN LACTATION" (RIORDAN AND WAMBACK, 4TH EDITION, PAGE 294)]. ADDITIONALLY, WE WILL CONTINUE TO ATTEMPT TO MAKE CONTACT TO GET ADDITIONAL COMPLAINT INFORMATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECT INFORMATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DEVICE POWER SEEMS SLOW/SLUGGISH WITH BOTH POWER SUPPLY/CHARGED BATTERY. MOM REPORTED SHE GOT MASTITIS BECAUSE SHE COULD NOT PUMP DUE TO NOT BEING ABLE TO TURN THE PUMP ON WITH BATTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34322 SWING BREAST PUMP HGX MEDELA, AG 67050

    Patients

    Seq Age Sex Outcome Treatment
    1