BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BREAST PUMP

    MDR report key: 2080642 · Received April 25, 2011

    Report

    Report Number
    1419937-2011-00092
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    PMA / PMN Number
    K053052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE COMPLETED TROUBLESHOOTING WITH THE CUSTOMER AND DETERMINED THAT THE CUSTOMER MAY NEED SMALLER BREAST SHIELDS. THE CUSTOMER WAS SENT 21MM BREAST SHIELDS AND NIPPLE SHIELDS TO ASSIST. IN COMPLAINT F/U ON (B)(4) 2011, THE CUSTOMER INDICATED THAT SHE FELT HER ISSUE WAS RELATED TO BREAST SHIELD SIZING; THAT THE 21MM BREAST SHIELDS SEEMED TO WORK BETTER, BUT SHE SAW BLEEDING THAT SHE FELT WAS RELATED TO HER ORIGINAL ISSUE. IN CLINICAL F/U ON (B)(4) 2011, SHE INDICATED THAT SHE INTENDED TO SEE A LACTATION CONSULTANT. ON (B)(4) 2011, CONTACT WAS MADE WITH THE CUSTOMER AFTER HER VISIT WITH THE LACTATION CONSULTANT. SHE INDICATED THAT SHE WAS ADVISED THAT THE 21MM BREAST SHIELDS WERE TOO SMALL AND THAT SHE SHOULD RENT A HOSPITAL GRADE PUMP. SHE WAS PRESCRIBED ANTIBIOTICS (V-PAK) FOR TREATMENT OF MASTITIS DIAGNOSED BY HER PHYSICIAN. A REPLACEMENT FREESTYLE PUMP WAS SENT TO THE CUSTOMER SO SHE COULD RETURN IT TO THE RETAIL STORE FOR A REFUND. "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 OF MASTITIS." ["BREASTFEEDING AND HUMAN LACTATION" (RIORDAN AND WAMBACH, 4TH EDITION, P. 294)]. THE PUMP WAS NOT RECEIVED FROM THE CUSTOMER FOR TESTING/ANALYSIS AS OF THE DATE OF THIS REPORT. SHOULD ADD'L INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILED. BASED ON THE FACT THAT THE PUMP IS NOT AVAILABLE FOR TESTING AND ANALYSIS, IT CANNOT BE DEFINITIVELY CONCLUDED THAT IT CAUSED OR CONTRIBUTED TO THE MASTITIS. WE WILL MONITOR COMPLAINTS FOR SIMILAR ISSUES. CLINICAL ASSESSMENT: PER TELEPHONE CONVERSATION WITH CUSTOMER ON (B)(4) 2011: PUMPING 2X/WEEK; SORE USING THE 21MM BREAST SHIELDS SENT TO HER; ADVISED CUSTOMER TO SEEK PROFESSIONAL HELP FROM A LACTATION PROFESSIONAL; SAID SHE WAS PLANNING ON SEEING A LACTATION CONSULTANT THIS WEEK; USING LANOLIN. PER TELEPHONE CONVERSATION WITH CUSTOMER ON (B)(4) 2011: LACTATION CONSULTANT SAID THE 21MM BREAST SHIELDS WERE TOO SMALL; ADVISED RENTING A HOSPITAL GRADE PUMP AND NOT TO CONTINUE USING FREESTYLE BREAST PUMP; CUSTOMER IS CURRENTLY ON ANTIBIOTICS (V-PAK) FOR TREATMENT OF MASTITIS DIAGNOSED BY HER PHYSICIAN; INFORMED CUSTOMER THAT MASTITIS NEEDS TO BE TREATED FOR 10-14 DAYS PER STANDARD GUIDELINES OR MAY REOCCUR; CUSTOMER IS USING A SYMPHONY BREAST PUMP WITH 24 MM PERSONAL FIT BREAST SHIELDS; PUMPING AND BREASTFEEDING ARE GOING WELL NOW; DISCOURAGED BECAUSE SHE WILL NOT BE USING THE FREESTYLE BREAST PUMP; WILL BE SENDING A PACKAGE FREESTYLE FOR CUSTOMER TO RETURN FOR STORE CREDIT. SUMMARY: REVIEWED COMPLAINT AND RESPONSE BY CUSTOMER SERVICE AND INTERACTION WITH QUALITY PERSONNEL AND CUSTOMER. CUSTOMER DEVELOPED MASTITIS USING THE FREESTYLE BREAST PUMP. SOFT FIT AND 21MM BREAST SHIELDS WERE NOT COMFORTABLE FOR CUSTOMER; SOUGHT MD AND LACTATION CONSULTANT ADVICE FOR BREAST SHIELD SIZING AND TREATMENT OF MASTITIS; CUSTOMER STATED SHE WAS 'ON A V-PAK' FOR 6 DAYS; EXPLAINED STANDARD OF ANTIBIOTIC THERAPY FOR MASTITIS WAS 10-14 DAYS (LAWRENCE AND LAWRENCE, "BREASTFEEDING: A GUIDE FOR THE MEDICAL PROFESSION." 6TH ED. 2005.) CUSTOMER IS NO LONGER USING THE FREESTYLE BREAST PUMP; USING A SYMPHONY BREAST PUMP WITH 24MM PERSONAL FIT BREAST SHIELDS; FEELING MUCH IMPROVED SINCE TAKING THE ANTIBIOTICS AND USING THE SYMPHONY BREST PUMP. "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 OF MASTITIS." RIORDAN AND WAMBACH; 4TH EDITION, P. 294, BREASTFEEDING AND HUMAN LACTATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT SHE PUMPS TWO DAYS A WEEK, 15 TO MINUTES PER PUMPING SESSION AND WAS HAVING ISSUES. HER NIPPLES CRACK AND IT IS PAINFUL TO PUMP. SHE FEELS THAT THE SUCTION IS TOO STRONG, SO SHE SINGLE PUMPS TO MAKE IT EASIER. WHEN SHE FINISHES PUMPING, HER BREASTS STILL FEEL FULL. IT IS ALSO PAINFUL WHEN SHE IS BREASTFEEDING HER BABY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BREAST PUMP HGX MEDELA AG 67060

    Patients

    Seq Age Sex Outcome Treatment
    1