BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

    MDR report key: 6522991 · Received April 26, 2017

    Report

    Report Number
    1419937-2017-00117
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    March 23, 2017
    Report Date
    April 26, 2017
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. IN FOLLOW UP WITH A MEDELA CLINICIAN ON 3/31/2017, THE CUSTOMER STATED THAT SHE RECEIVED AN ANTIBIOTIC FOR THE MASTITIS. IN AN ADDITIONAL FOLLOW UP ON 4/13/2017, THE CUSTOMER STATED THAT SHE WAS DIAGNOSED WITH MASTITIS BY HER OB DOCTOR AND HER MASTITIS IS NOW RESOLVED. THOUGH THE PRODUCT HAS BEEN RECEIVED, IT HAS NOT YET BEEN TESTED/ANALYZED BY QUALITY ENGINEERING. 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 TO CUSTOMER SERVICE ON (B)(6) 2017, THAT SHE HAD LOW SUCTION AND WAS NOT EXPRESSING MILK, WHILE USING THE PUMP IN STYLE ADVANCED BREAST PUMP. THE CUSTOMER ALSO MENTIONED SHE HAD MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303233 PUMP IN STYLE ADVANCED - ON-THE-GO TOTE PUMP, BREAST, POWERED HGX MEDELA LLC 57063 433346

    Patients

    Seq Age Sex Outcome Treatment
    1 Other