BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK

    MDR report key: 7107539 · Received December 12, 2017

    Report

    Report Number
    1419937-2017-00345
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 12, 2017
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. A MEDELA LACTATION CONSULTANT SPOKE TO THE CUSTOMER, WHO STATED THAT HER NIPPLES WERE SORE AND CRACKED FROM PUMPING AND SHE WENT TO HER OBSTETRICIAN AND WAS PRESCRIBED ANTIBIOTICS FOR MASTITIS. SHE INDICATED THAT THE REPLACEMENT PUMP WAS WORKING WITHOUT ISSUE AND THAT SHE WAS USING LANOLIN ON HER NIPPLES, WHICH ARE HEALING WELL. THE ORIGINAL DEVICE WAS EVALUATED WITH THE CUSTOMER'S PARTS/ACCESSORIES AND, THOUGH THE DEVICE MET ALL VACUUM SPECIFICATIONS, IT WAS NOTED THAT ONE OF THE TWO VALVES WAS DAMAGED AND THE OTHER VALVE, ALONG WITH THE TUBING, HAD RESIDUE ON THEM. IT WAS ALSO NOTED THAT THE POWER SUPPLY HAD NO VOLTAGE OUTPUT AND ONE PRONG WAS BENT. REFER TO ATTACHED EVALUATION. 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 (B)(4)%. 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) 2017, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE SUCTION ON HER PUMP IN STYLE ADVANCED BREAST PUMP WAS LOW AND WOULD NOT EMPTY HER BREASTS, EVEN WHEN THE VACUUM LEVEL WAS INCREASED. SHE STATED THAT IF SHE DOES NOT SET THE VACUUM LEVEL TO AT LEAST THE HALFWAY POINT, SHE DOESN'T FEEL SUCTION AND, IF SHE INCREASES IT MORE, IT CAUSES PAIN. SHE ALLEGED THAT IT CAUSED NIPPLE DAMAGE AND CLOGGED DUCTS AND, BECAUSE OF THE PAIN, SHE HAD TO GO TO THE EMERGENCY ROOM. SHE WAS GIVEN A PRESCRIPTION FOR ANTIBIOTICS, BUT WAS INSTRUCTED TO ONLY TAKE THEM IF SHE DEVELOPED MASTITIS. THE CUSTOMER ALSO ALLEGED THAT THE POWER SUPPLY WOULD NOT TURN HER PUMP ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887396 PUMP IN STYLE ADVANCED BREASTPUMP - BACKPACK PUMP, BREAST, POWERED HGX MEDELA LLC 57062 433236

    Patients

    Seq Age Sex Outcome Treatment
    1 Other