BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 6129832 · Received November 28, 2016

    Report

    Report Number
    1419937-2016-00302
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 28, 2016
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT BREASTPUMP. ON 11/09/2016 IN FOLLOW UP WITH A MEDELA CLINICIAN THE CUSTOMER STATED SHE WAS DIAGNOSED WITH MASTITIS AND PRESCRIBED AN ANTIBIOTIC BY HER PHYSICIAN. THE DEVICE WAS TESTED AND PASSED ALL FUNCTIONAL TEST, NO DEFINITIVE CONCLUSION REGARDING THE CAUSE OF THE REPORTED EVENT CAN BE DETERMINED. SEE ATTACHED PRODUCT EVALUATION. 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 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

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE ON (B)(6) 2016, THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE ADVANCED STARTER BREASTPUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779918 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA INC 57081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other