BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE BREAST PUMP

    MDR report key: 2212569 · Received August 11, 2011

    Report

    Report Number
    1419937-2011-00162
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE SENT A REPLACEMENT PUMP TO THE CUSTOMER. IN FOLLOW UP WITH THE CUSTOMER, SHE INDICATED THAT PRIMARILY PUMPS MILK FOR HER BABY, BUT DOES ALSO BREAST FEED. SHE HAD BEEN USING THE BREAST PUMP WITHOUT ISSUE AND THEN WHEN SHE WENT TO USE IT, IT WAS ONLY WORKING ON ONE SIDE AND SHE EXPERIENCED POOR EXPRESSION OF MILK. MASTITIS DEVELOPED AND HER PHYSICIAN TREATED HER WITH ANTIBIOTICS SUCCESSFULLY. HER MASTITIS HAS SINCE RESOLVED. SHE TRIED TO PUMP DURING THE EARLY ONSET OF MASTITIS, BUT OUTPUT OF MILK WAS LOW. AS THE MASTITIS RESOLVED, HER MILK SUPPLY CONTINUED TO BE LOW AND SHE HAS STOPPED BREAST FEEDING FOR THAT REASON. SHE HAS RECEIVED THE REPLACEMENT PUMP THAT WAS SENT TO HER AND SHE HOPES TO USE IT WITH SUBSEQUENT BABIES. SHE HAS NOT YET SENT BACK HER ORIGINAL PUMP, BUT WILL DO SO SOON. "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 OF MASTITIS." ["BREASTFEEDING AND HUMAN LACTATION" (RIORDAN AND WAMBACH, 4TH EDITION, PAGE 294)]. AS OF THE DATE OF THIS REPORT, THE BREAST PUMP HAS NOT BEEN RETURNED BY THE CUSTOMER FOR TESTING/ANALYSIS. BASED ON THE FACT THAT THE PUMP HAS NOT BEEN TESTED/ANALYZED, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE MASTITIS. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT HER BREAST PUMP IS NOT WORKING; SHE IS EXPERIENCING SUCTION AND POWER ISSUES. SHE HAS MASTITIS AND CAN ONLY PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE BREAST PUMP HGX MEDELA, INC. 57062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other