BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 6129843 · Received November 28, 2016

    Report

    Report Number
    1419937-2016-00303
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    November 18, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP. THE CUSTOMER FOLLOWED UP WITH A MEDELA CLINICIAN ON 11/18/2016, SHE STATED SHE WAS PUT ON ANTIBIOTICS BY HER PHYSICIAN FOR ABOUT A WEEK AND THEN WAS HOSPITALIZED AND ON AN IV ANTIBIOTIC. SHE IS CURRENTLY ON KEFLEX FOR 10 DAYS. WHILE THE DEVICE DID TEST TO SPECIFICATIONS, NO DEFINITIVE CONCLUSION REGARDING THE CAUSE OF THE REPORTED EVENT CAN BE DETERMINED. SEE ATTACHED PRODUCT EVALUATION. THE TECHNICIAN NOTED THAT THE VALVE WAS DIRTY AND THE MEMBRANE WAS DAMAGED. 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. THE CUSTOMER ALSO STATED SHE HAD MASTITIS TWICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779824 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA INC 57081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other