BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 7340751 · Received March 15, 2018

    Report

    Report Number
    1419937-2018-00081
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    March 2, 2018
    Report Date
    March 14, 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

    CUSTOMER SERVICE SENT THE CUSTOMER A TROUBLESHOOTING VIDEO. ON (B)(6) 2018, THE CUSTOMER CALLED MEDELA CUSTOMER SERVICE TO PERFORM TROUBLESHOOTING OVER THE PHONE. DURING THE CALL, THE CUSTOMER INDICATED THAT SHE RECEIVED THE PUMP, UNSEALED AND WITHOUT ANY OF THE PARTS/ACCESSORIES, FROM A FRIEND AND SHE WASN'T SURE IF HER FRIED HAD PREVIOUSLY USED THE PUMP. CUSTOMER SERVICE REQUESTED RETURN OF THE PUMP FOR TESTING/EVALUATION. BASED ON THE RESULTS OF (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 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) 2018 THE MOTHER OF A CUSTOMER ALLEGED TO MEDELA LLC THAT HER DAUGHTER'S PUMP IN STYLE BREAST PUMP WAS NOT PUMPING AS WELL AS IT INITIALLY DID AND HER DAUGHTER HAD MASTITIS, FOR WHICH SHE WAS ON ANTIBIOTICS FOR ABOUT 7 - 10 DAYS. SHE INDICATED THAT THE MASTITIS WAS RESOLVED, BUT SHE WAS CONCERNED THAT IT WOULD RECUR. SHE SWITCHED TO A COMPETITOR BREAST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183589 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA LLC 57081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other