BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

    MDR report key: 7422731 · Received April 11, 2018

    Report

    Report Number
    1419937-2018-00097
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    March 19, 2018
    Report Date
    April 23, 2018
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER, ON 04/09/2018 THE CUSTOMER INDICATED THAT THE REPLACEMENT PUMP WAS WORKING WITHOUT ISSUE AND THAT SHE HAD FULLY RECOVERED FROM THE MASTITIS. SHE CONFIRMED THAT SHE RETURNED THE ORIGINAL PUMP BACK TO MEDELA, THOUGH IT HAD NOT BEEN RECEIVED 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 OR MASTITIS." RIORDAN AND 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED WITHOUT THE CUSTOMER'S PARTS AND ACCESSORIES; THEREFORE, IT WAS EVALUATED WITH A MEDELA LAB KIT ON 04/17/2018 AND IT PASSED SUCTION AND CYCLE SPECIFICATIONS. THE CUSTOMER'S COMPLAINT OF LOW SUCTION COULD NOT BE CONFIRMED. [(B)(4)].

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE BREAST PUMP. AFTER TROUBLESHOOTING, IT WAS DETERMINED THAT THERE WAS A KIT CLEANING/ASSEMBLY ISSUE. ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE SUCTION WAS LOW AGAIN AND SHE FURTHER ALLEGED THAT SHE WAS DIAGNOSED WITH MASTITIS ON (B)(6) 2018, FOR WHICH SHE WAS PRESCRIBED AN ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265154 PUMP IN STYLE ADVANCED - ON-THE-GO TOTE PUMP, BREAST, POWERED HGX MEDELA LLC 57063 436022

    Patients

    Seq Age Sex Outcome Treatment
    1 Other