BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN)

    MDR report key: 17208888 · Received June 27, 2023

    Report

    Report Number
    1419937-2023-00024
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    June 19, 2023
    Report Date
    June 27, 2023
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451401447
    PMA / PMN Number
    K200508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER INCLUDING, VERIFYING NO MILK BACKUP OCCURRED; INSPECTING TRANSFORMER FOR DAMAGED; TRYING TO POWER DEVICE ON WITH TRANSFORMER. THE CUSTOMER STATED DURING TROUBLESHOOTING THAT THE PUMP WILL SHUT OFF RANDOMLY. SHE ALSO STATED SHE DOESN'T THINK TRYING THE PORTABLE BATTERY PACK WILL POWER THE PUMP ON. CUSTOMER SERVICE SENT OUT THE CUSTOMER A NEW PUMP IN STYLE WITH MAXFLOW PUMP. THE CUSTOMER WAS CONTACTED BY A COMPLAINT HANDLER ON MULTIPLE OCCASIONS, INCLUDING IN WRITING, TO GET ADDITIONAL INFORMATION, WITH NO RESPONSE AS OF THE DATE OF THIS REPORT. 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 33%. IN FACT, CLINICAL GUIDELINES SUGGEST THE USE OF A BREAST PUMP TO FACILITATE WITHDRAWAL OF BREAST MILK DURING BOUTS OF MASTITIS. (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 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 6/20/2023, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE WITH MAXFLOW PUMP WAS EXPERIENCING POWER ISSUES. THE CUSTOMER ALSO ALLEGED SHE WAS DIAGNOSED WITH MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930636 PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN) PUMP, BREAST, POWERED HGX MEDELA LLC 101041360 0000430688 00020451401447

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other