BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE (UNKNOWN)

    MDR report key: 6256981 · Received January 17, 2017

    Report

    Report Number
    1419937-2017-00010
    Event Type
    Injury
    Date Received
    January 17, 2017
    Date of Event
    December 9, 2016
    Report Date
    January 17, 2017
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP. ON 1/9/2016 THE CUSTOMER EMAILED THAT SHE HAD BEEN  DIAGNOSED WITH MASTITIS THAT STARTED ON (B)(6) 2016, SHE WAS PRESCRIBED THE ANTIBIOTIC PENICILLIN AND THEN CHANGED TO DICLOXACILLIN BY HER OB. AS  OF 1/9/2016 THE MASTITIS HAS CLEARED AND SHE HAD RECEIVED HER NEW PUMP. 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 12/29/2016 THAT SHE HAD LOW SUCTION WITH HER PUMP IN STYLE AND DUE TO NOT BEING ABLE TO PUMP SHE HAD MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40377 PUMP IN STYLE (UNKNOWN) PUMP, BREAST, POWERED HGX MEDELA LLC PUMP IN STYLE (UNKNOWN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other