BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMPLISSE

    MDR report key: 2061072 · Received March 10, 2011

    Report

    Report Number
    3008138005-2011-00002
    Event Type
    Other
    Date Received
    March 10, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 9, 2011
    Manufacturer
    SIMPLISSE INC.
    Product Code
    HGY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE ATTEMPTED TO OBTAIN MORE INFORMATION REGARDING THE DEVICE (LOT NUMBER) AND CUSTOMER DETAILS SUCH AS AGE, WEIGHT, TIME OF EVENT AND WAS UNSUCCESSFUL.

    Description of Event or Problem · 1

    ON (B)(6)-2011, CUSTOMER CALLED AND SAID SHE IS UNABLE TO EXPRESS USING THE SIMPLISSE SINGLE MANUAL PUMP. HER BABY IS NOT EATING AS MUCH AND SHE IS ENGORGED AND VERY SORE. SIMPLISSE CUSTOMER SERVICE ENSURED PUMP WAS ASSEMBLED AND WORKING PROPERLY VIA PHONE. SHE HAS TAKEN A WARM SHOWER AND RECOMMEND THAT SHE HAND EXPRESS WHILE EXPRESSING. ALSO, TO TRY TO GET THE BABY TO NURSE BUT SHE SAID THE BABY IS NOT HUNGRY. IT WAS DETERMINED THE CUSTOMER HAD MASTITIS OF HER RIGHT BREAST. THE DOCTOR DID DIAGNOSE MASTITIS DUE TO DECREASED BREASTFEEDING AND PRESCRIBED ANTIBIOTICS. SHE IS FEELING BETTER TODAY THOUGH STILL SORE. SHE WAS ABLE TO PUMP AND THE BABY IS BREASTFEEDING JUST FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLISSE MANUAL BREAST PUMP HGY SIMPLISSE INC. S1001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other