BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE RETAIL EN FR ES (YELLOWFIN)

    MDR report key: 11530811 · Received March 19, 2021

    Report

    Report Number
    1419937-2021-00022
    Event Type
    Injury
    Date Received
    March 19, 2021
    Date of Event
    February 24, 2021
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451401454
    PMA / PMN Number
    K200508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING TRYING TO POWER THE PUMP ON AND TRYING MULTIPLE OUTLETS. THE CUSTOMER WAS SENT A REPLACEMENT DEVICE AND RETURN OF HER ORIGINAL DEVICE WAS REQUESTED FOR TESTING/EVALUATION. 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 CA11-001, 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. 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

    ON (B)(6) 2021, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAXFLOW BREAST PUMP WAS POWERING OFF ON ITS OWN AFTER TWO MINUTES. SHE ADDITIONALLY ALLEGED THAT SHE HAD TO GO TO THE HOSPITAL BECAUSE SHE HAD MASTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419927 PUMP IN STYLE RETAIL EN FR ES (YELLOWFIN) PUMP, BREAST, POWERED HGX MEDELA LLC 101041361 0000017580 00020451401454

    Patients

    Seq Age Sex Outcome Treatment
    1 Other