BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 7494132 · Received May 8, 2018

    Report

    Report Number
    1419937-2018-00123
    Event Type
    Injury
    Date Received
    May 8, 2018
    Date of Event
    April 24, 2018
    Report Date
    June 21, 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 CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING INSPECTING THE FACEPLATE AND BACK PLATE FOR DAMAGE; INSPECTING AND CLEANING THE DIAPHRAGM AND VERIFYING BREAST SHIELD FIT. 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 TO GET ADDITIONAL INFORMATION AND THE CUSTOMER RESPONDED THAT THEY WERE OUT OF THE COUNTRY AND WOULD RESPOND WHEN THEY RETURN. FOLLOW UP WITH THE CUSTOMER IS ON-GOING. 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 WITH THE POWER SUPPLY, BUT WITHOUT THE REMAINING PARTS AND ACCESSORIES; THEREFORE, IT WAS EVALUATED WITH A MEDELA LAB KIT ON 06/05/2018. THE DEVICE WOULD NOT POWER ON WITH THE RETURNED POWER SUPPLY (DUE TO A BLOWN FUSE), SO IT WAS TESTED WITH A MEDELA POWER SUPPLY AND PASSED SUCTION AND CYCLE SPECIFICATIONS. REFER TO ATTACHED EVALUATION. THE CUSTOMER'S REPORT OF LOW SUCTION COULD NOT BE CONFIRMED. [(B)(4)].

    Additional Manufacturer Narrative · 1

    IN FOLLOW UP WITH A COMPLAINT HANDLER ON 05/11/2018, THE CUSTOMER INDICATED THAT SHE WAS PRESCRIBED AN ANTIBIOTIC, THAT THE REPLACEMENT PUMP WAS WORKING WITHOUT ISSUE AND HER MASTITIS WAS RESOLVED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE SUCTION ON HER PUMP IN STYLE BREAST PUMP WAS LOW AND SHE HAD MASTITIS, WHICH SHE SELF-DIAGNOSED AS SHE IS A DOCTOR AND A LACTATION CONSULTANT. SHE INDICATED THAT SHE WAS NOT ON MEDICATION, BUT WAS PLANNING ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339704 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA LLC 57081 422212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other