BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN)

    MDR report key: 11285435 · Received February 5, 2021

    Report

    Report Number
    1419937-2021-00006
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    December 8, 2020
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    UDI-DI
    00020451401447
    PMA / PMN Number
    K200508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED WITH THE CUSTOMER'S TUBING. THE DEVICE WAS EVALUATED WITH THE CUSTOMER'S TUBING AND LAB KIT ON (B)(6) 2021. THE DEVICE PASSED SUCTION AND CYCLE SPECIFICATIONS. THE CUSTOMER'S REPORT OF LOW SUCTION COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2021, THE CUSTOMER CONTACTED CUSTOMER SERVICE AND ALLEGED SHE HAD MASTITIS FROM NOT BEING ABLE TO PUMP WITH HER MEDELA BREAST PUMP AND SHE HAD BEEN PRESCRIBED MEDICATION. THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF HER ORIGINAL PUMP 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 (B)(6) 2013 TO (B)(6) 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 OR 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) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION ON ONE SIDE WHEN THE LETDOWN PHASE BEGINS WITH HER PUMP IN STYLE MAX FLOW BREAST PUMP. SHE ADDITIONALLY ALLEGED SHE HAD ALREADY DONE TROUBLESHOOTING WITH HER PARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181506 PUMP IN STYLE MANAGED MARKETS EN FR ES (YELLOWFIN) PUMP, BREAST, POWERED HGX MEDELA LLC 101041360 0000014581 00020451401447

    Patients

    Seq Age Sex Outcome Treatment
    1 Other