BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN)

    MDR report key: 14605134 · Received June 6, 2022

    Report

    Report Number
    1419937-2022-00052
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    May 8, 2022
    Report Date
    June 6, 2022
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451401447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2022, THE CUSTOMER INDICATED THAT SHE DEVELOPED MASTITIS ON (B)(6) 2022 AND WAS PRESCRIBED AN ANTIBIOTIC. SHE INDICATED THAT THE REPLACEMENT PUMP WAS WORKING WITHOUT ISSUE AND HER MASTITIS IS BETTER. THE DEVICE WAS RETURNED AND EVALUATED ON (B)(6) 2022 AND IT WAS DETERMINED THAT THE DC JACK WAS MISALIGNED AND THE PUMP HOUSING, KEYPAD, CHASSIS AND PC BOARD ARE DAMAGED. THE CUSTOMER'S REPORT OF BROKEN DAMAGED DC JACK WAS CONFIRMED. BASED ON THE RESULTS OF OUR INTERNAL INVESTIGATION ((B)(4)), IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S MASTITIS. THE ESTIMATED INCIDENCE OF MASTITIS IN LACTATING WOMEN, WHETHER USING A BREAST PUMP OR NOT, ACCORDING TO PUBLISHED CLINICAL LITERATURE CAN BE AS HIGH AS 33%. IN FACT, CLINICAL GUIDELINES SUGGEST THE USE OF A BREAST PUMP TO FACILITATE WITHDRAWAL OF BREAST MILK DURING BOUTS OF MASTITIS. THE COMPLAINT RATE OF MASTITIS ACROSS ALL REPORTED FAILURES, ACROSS ALL MEDELA BREAST PUMPS, IS 0.008% FOR THE PERIOD OF JANUARY 2013 TO AUGUST 2017. 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. RIORDAN & WAMBACH, 4TH ED. P. 294: BREASTFEEDING AND HUMAN LACTATION. HOWEVER IN THIS CASE, THE MOTHER¿S MASTITIS REQUIRED PROMPT MEDICAL ATTENTION FOR PAIN RELIEF AND PRESCRIPTION ANTIBIOTICS TO AVOID PROGRESSION TO OVERWHELMING SEPSIS.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE DC JACK ON HER PUMP IN STYLE MAX FLOW IS BROKEN AND SHE IS STARTING TO GET MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306428 PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN) PUMP, BREAST, POWERED HGX MEDELA LLC 101041360 00020451401447

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other