BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE

    MDR report key: 3133097 · Received May 24, 2013

    Report

    Report Number
    1419937-2013-00283
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IN FOLLOW-UP WITH THE CUSTOMER REPORTED THAT SHE HAS ONE BREAST THAT CONTINUES TO GET MASTITIS. SHE ALSO STATED THAT SHE USED TO HAVE PAIN AND BLISTERING BUT THAT SEEMED TO GO AWAY. SHE HAS NOT CONSULTED WITH A DOCTOR OR LACTATION SPECIALIST BUT SHE THINKS SHE NEEDS A LARGER SIZE BREASTSHIELD ON THE ONE SIDE. SHE SAYS THAT SHE HAS HAD MASTITIS SEVERAL TIMES BUT SHE WAS ABLE TO MANAGE THE INFECTION AND IT WOULD GO AWAY, BUT THEN COME BACK. A MEDELA CLINICIAN SPOKE WITH THE CUSTOMER AND SHE INDICATED THAT SHE SELF-TREATED THIS TWICE WITH WARM PACKS. AFTER FREQUENT PUMPING AND NURSING, AND WITH A THIRD OCCURRENCE, WAS TREATED WITH ANTIBIOTICS BY HER PHYSICIAN. SHE IS NOW FULLY RECOVERED. PROBLEMS BEGAN IN HOSPITAL WITH BABY CAUSING A CUT ON ONE NIPPLE WHICH IS FLAT AND DIFFICULT TO LATCH. SUBSEQUENTLY, WHEN PUMPING, THE CUT REOPENED EACH TIME AND WOULD NOT HEAL. SHE HAS SEEN LC WHO ADVISED MEDICAL TREATMENT AND IS HELPING HER AND THE CORRECT SIZES OF BREAST SHIELDS TO ACCOMMODATE TWO DIFFERENT SIZE NIPPLES. ADVISED LUBRICATING NIPPLE TUNNEL TO PREVENT FRICTION AND BLISTERING. THIS ISSUE IS RESOLVED WITHOUT ONGOING ADVERSE EFFECT. "MASTITIS IS USUALLY A BENIGN, SELF-LIMITING INFECTION WITH FEW CONSEQUENCES FOR THE SUCKING 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". IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER'S MASTITIS. REPORTED ISSUES OF MASTITIS ARE UNDER INVESTIGATION IN (B)(4). SHOULD ADDITIONAL INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A FOLLOW UP REPORT WILL BE FILED. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT WHEN SHE PUMPED, SEEMED TO HAVE DISCOMFORT AND SORENESS WHEN PUMPING. SHE ALSO REPORTED THAT ONE BREAST CONTINUES TO GET MASTITIS AND THAT SHE USED TO HAVE BLISTERS THAT SEEMED TO GO AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231936 PUMP IN STYLE HGX MEDELA, INC. 57XXX/UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1