BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 2992346 · Received March 1, 2013

    Report

    Report Number
    1419937-2013-00133
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER ON (B)(6) 2013, THE CUSTOMER INDICATED THAT SHE WAS NOT EXPRESSING AS MUCH MILK AS USUAL. SHE ALSO STATED THAT SHE HAD RECEIVED DICLOXACILLIN TO TREAT MASTITIS THAT WAS DIAGNOSED BY HER OBGYN. THE CUSTOMER ALSO REPORTED THAT THE ORIGINAL PUMP WAS SENT BACK TO MEDELA. HOWEVER, AS OF THE DATE OF THIS REPORT THE ORIGINAL PRODUCT WAS NOT RECEIVED. SHOULD THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. A MEDELA CLINICIAN SPOKE TO THE CUSTOMER ON (B)(4) 2013, AT WHICH TIME THE CUSTOMER CONFIRMED THAT HER ISSUES WERE RESOLVED WITH THE ANTIBIOTICS. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S MASTITIS. REPORTED ISSUES OF MASTITIS ARE UNDER INVESTIGATION IN (B)(4). "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 HISTORY OF MASTITIS." [BREASTFEEDING AND HUMAN LACTATION" (RIORDAN AND WAMBACH, 4TH EDITION, PAGE 294)].

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE BREAST PUMP. SHE ALSO REPORTED THAT SHE HAD MASTITIS AND HAD RECEIVED ANTIBIOTICS FROM A PHYSICIAN TO TREAT THE MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89912 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063

    Patients

    Seq Age Sex Outcome Treatment
    1