BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDELA

    MDR report key: 441137 · Received January 31, 2003

    Report

    Report Number
    MW1027434
    Event Type
    Other
    Date Received
    January 31, 2003
    Date of Event
    October 2, 2002
    Report Date
    January 31, 2003
    Manufacturer
    MEDELA, INC.
    Product Code
    HGY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHEN APPLYING THE MEDELA HAND PUMP TO THEIR ENGORGED BREAST TO RELIEVE THE PAIN AND PRESSURE, THE SUCTION CREATED ON THE NIPPLE TISSUE WAS SO GREAT THAT IT PULLED TO THE SURFACE A CLOT. THIS ACTION TORE APPROXIMATELY 1/4 OF THE NIPPLE OFF RESULTING IN BLEEDING AND LEAVING THE BREAST SUSCEPTIBLE TO INFECTION. THE INFECTION WAS TREATED WITH ANTIBIOTICS, HOWEVER THE NIPPLE DID NOT HEAL FOR 7 WEEKS AND MADE SUCCESSFUL BREASTFEEDING NEARLY IMPOSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDELA MANUAL BREASTPUMP HGY MEDELA, INC. 50313 S02572

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other