BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN)

    MDR report key: 13580985 · Received February 22, 2022

    Report

    Report Number
    1419937-2022-00018
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    January 31, 2022
    Report Date
    February 22, 2022
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451401447
    PMA / PMN Number
    K200508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING VERIFYING CORRECT KIT COMPONENTS WERE BEING USED, VERIFIED USER WAS USING CORRECT KIT COMPONENTS WASHED, AND DRIED ACCORDING TO OUR INSTRUCTIONS FOR USE; VERIFIED USER WAS NOT WASHING OR DRYING TUBING ON PUMP AND VERIFYING NO MILK BACKUP HAD OCCURRED. A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 2/09/2022, THE CUSTOMER STATED THAT SHE DEVELOPED MASTITIS ON (B)(6) 2022 AND WAS PRESCRIBED MEDICATION. ADDITIONALLY SHE STATED THAT HER MASTITIS IS RESOLVED AND THE REPLACEMENT PUMP IS WORKING WELL. THE DEVICE WAS RETURNED WITHOUT THE CUSTOMER'S PARTS AND ACCESSORIES; THEREFORE, IT WAS EVALUATED WITH A MEDELA LAB KIT AND POWER SUPPLY ON 02/21/2022 AND IT PASSED SUCTION AND CYCLE SPECIFICATIONS. THE CUSTOMER'S REPORT OF LOW SUCTION COULD NOT BE CONFIRMED. 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 (B)(6) 2022, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER PUMP IN STYLE MAX FLOW HAD LOW SUCTION WHICH HAS CAUSED HER TO DEVELOP MASTITIS AND CLOGGED DUCTS NUMEROUS TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847150 PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN) PUMP, BREAST, POWERED HGX MEDELA LLC 101041360 0000022917 00020451401447

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other