BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 6198834 · Received December 22, 2016

    Report

    Report Number
    1419937-2016-00325
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    December 20, 2016
    Report Date
    December 22, 2016
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP .  IN FOLLOW UP WITH THE CUSTOMER ON 12/22/2016 , THE CUSTOMER STATED THAT SHE HAD MASTITIS PREVIOUSLY WHILE USING HER PUMP IN STYLE.  SHE DEVELOPED MASTITIS ON (B)(6) 2016 AND STARTED TAKING THE ANTIBIOTIC DICLOXACILLIN, HER MASTITIS WAS RESOLVED BY (B)(6) 2016.  THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME.  THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. 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 A HISTORY OR MASTITIS."  RIORDAN & WAMBACH, 4TH ED. P. 294: BREASTFEEDING AND HUMAN LACTATION. MASTITIS REQUIRES PROMPT MEDICAL ATTENTION FOR THE MOTHER FOR PAIN RELIEF AND PRESCRIPTION ANTIBIOTICS TO AVOID PROGRESSION TO OVERWHELMING SEPSIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON 12/20/2016 THAT SHE WAS GETTING CLOGGED DUCTS DUE TO LOW SUCTION WITH HER PUMP IN STYLE PUMP, AND SHE HAD PREVIOUSLY HAD MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850400 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA INC 57081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other