BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE WARRANTY EN FR ES (YELLOWFIN)

    MDR report key: 14280561 · Received May 4, 2022

    Report

    Report Number
    1419937-2022-00043
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    March 25, 2022
    Report Date
    May 3, 2022
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451412658
    PMA / PMN Number
    K200508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING INCLUDING; VERIFYING BATTERY COUNT; IF THE DEVICE POWERED ON WITH THE BATTERY PACK; AND IF THE DEVICE POWERED ON WITH THE TRANSFORMER. THE PUMP POWERED UP FINE USING THE TRANSFORMER. THE CUSTOMER SEES NO VISIBLE DAMAGE ON THE BATTERY PACK BUT THE PUMP SHUTS OFF AFTER 2 MINUTES WHEN USING THE BATTERY PACK. THE CUSTOMER WAS FIRST SENT A NEW BATTERY PACK AND THEN WAS SENT A NEW BREAST PUMP. IT WAS REQUESTED THAT SHE RETURN HER BATTERY PACK AND PUMP TO MEDELA FOR TESTING AND ANALYSIS. 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. 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) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW BREAST PUMP WORKS WITH THE POWER CORD BUT DOESN'T POWER ON WITH THE BATTERY PACK. ON 04/01/2022, SHE CONTACTED US BACK. SHE HAS TRIED NEW BATTERIES AND STILL IS HAVING ISSUES. ON 04/15/2022, SHE CONTACTED US AGAIN AND IS STILL HAVING BATTERY PACK ISSUES AND NOW HAS MASTITIS AND WAS PRESCRIBED AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380796 PUMP IN STYLE WARRANTY EN FR ES (YELLOWFIN) PUMP, BREAST, POWERED HGX MEDELA LLC 101041265 0000037233 00020451412658

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other