BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 5025924 · Received August 24, 2015

    Report

    Report Number
    1419937-2015-00250
    Event Type
    Injury
    Date Received
    August 24, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 24, 2015
    Manufacturer
    MEDELA INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    MEDELA CUSTOMER SERVICE SENT THE CUSTOMER THE NEXT LARGER SIZE (30 MM) BREAST SHIELDS AND REQUESTED THE CUSTOMER TO CONTACT A LACTATION CONSULTANT TO BE PROPERLY FITTED FOR BREAST SHIELDS. ON (B)(6) 2015, THE CLINICAL ASSESSMENT INDICATED THAT THE NEW 30 MM BREAST SHIELDS HAVE BEEN WORKING WELL. SHE IS NO LONGER EXPERIENCING SYMPTOMS OF MASTITIS. THE CUSTOMER ALSO STATED BREASTFEEDING DIFFICULTIES. THE CLINICIAN INFORMED THE CUSTOMER ABOUT TUGGING EXERCISES WITH USE OF PACIFIER TO STRENGTHEN THE BABIES SUCKING ABILITY. SHE ALSO RECOMMENDED SEEING A LACTATION CONSULTANT FOR LATCHING ASSISTANCE. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THAT TIME. 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). "MASTITIS IS USUALLY A BENIGN, SELF- LIMITING INFECTION, WITH FEW CONSEQUENCES FOR 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 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

    THE CUSTOMER CALLED MEDELA CUSTOMER SERVICE STATING THE 27 MM BREAST SHIELDS FOR HER PUMP IN STYLE BREAST PUMP DON'T FIT RIGHT. THE DOCTOR DIAGNOSED HER WITH A MASTITIS INFECTION AND PRESCRIBED HER THE ANTIBIOTIC KEFLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557279 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX HGX MEDELA INC. 8107176 (87274)_57063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other