BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 6613956 · Received June 6, 2017

    Report

    Report Number
    1419937-2017-00162
    Event Type
    Injury
    Date Received
    June 6, 2017
    Date of Event
    May 10, 2017
    Report Date
    June 6, 2017
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP. IN FOLLOW UP WITH A MEDELA CLINICIAN ON (B)(6) 2017, THE CUSTOMER REPORTED THAT SHE WAS DIAGNOSED WITH MASTITIS BY HER OB AND WAS PRESCRIBED AN ANTIBIOTIC. THE CUSTOMER ADDITIONALLY REPORTED THAT HER MASTITIS IS RESOLVED. BASED ON THE RESULTS OF CA11-001, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE PUMP CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S MASTITIS. 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

    ON (B)(6) 2017, THE CUSTOMER ALLEGED THAT SHE WAS EXPERIENCING LOW SUCTION WITH HER PUMP IN STYLE BREAST PUMP. SHE HAS MASTITIS AND A LACTATION CONSULTANT INDICATED THAT SHE NEEDS A PUMP THAT WILL "DRAIN" AND PUMP CORRECTLY AFTER HER BABY IS DONE FEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395594 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA LLC 57081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other