BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN)

    MDR report key: 18796097 · Received February 28, 2024

    Report

    Report Number
    1419937-2024-00006
    Event Type
    Injury
    Date Received
    February 28, 2024
    Date of Event
    February 23, 2024
    Report Date
    February 28, 2024
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451401447
    PMA / PMN Number
    K200508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING VERIFYING IF CUSTOMER WAS USING CORRECT KIT COMPONENTS; VERIFYING USER WAS WASHING PARTS ACCORDING TO IFU; VERIFYING USER WAS USING DRY PARTS WHEN PUMPING; VERIFYING NO MILK BACKUP OCCURRED; POWERED PUMP ON WITH BATTERY PACK; VERIFYING THE CORRECT BATTERY COUNT AND QUALITY/AGE; AND POWERED ON DEVICE WITH TRANSFORMER. THE CUSTOMER WAS SENT A NEW PUMP. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 02/27/24, THE CUSTOMER INDICATED THAT SHE DEVELOPED MASTITIS ON (B)(6) 2024 AND WAS PRESCRIBED AN ANTIBIOTIC. SHE INDICATED THE MASTITIS SYMPTOMS HAVE CLEARED UP AND SHE IS FINISHING HER ANTIBIOTIC. BASED ON THE RESULTS OF OUR INTERNAL INVESTIGATION (REFERENCE NUMBER (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 (B)(4). 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 (B)(4) 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) 2024, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAXFLOW IS HAVING POWER AND SUCTION ISSUES. THE CUSTOMER ALSO ALLEGED SHE HAD BEEN DIAGNOSED WITH MASTITIS AND PRESCRIBED MEDICATION TO TREAT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223972 PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN) PUMP, BREAST, POWERED HGX MEDELA LLC 101041360 0000608027 00020451401447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other