BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 6132154 · Received November 29, 2016

    Report

    Report Number
    1419937-2016-00305
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 9, 2016
    Report Date
    November 29, 2016
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP TO HELP RESOLVE THE ISSUE. THE CUSTOMER WAS CONTACTED ON (B)(6) 2016, AND STATED THAT SHE HAD MASTITIS WAS DIAGNOSED BY HER PHYSICIAN ON (B)(6) 2016, AND HAD TAKEN CLINDAMYCIN FOR 10 DAYS. THE CUSTOMER STATED THAT THE NEW PUMP IS WORKING WELL. IN FOLLOW UP WITH THE CUSTOMER ON (B)(6) 2016, THE CUSTOMER STATED HER MASTITIS HAS BEEN RESOLVED. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSION CAN BE MADE AS THE CAUSE OF THE EVENT. 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 HAD NOTICED A LOSS OF SUCTION WITH HER PUMP IN STYLE BREASTPUMP. ON (B)(6) 2016, THE CUSTOMER CALLED BACK TO NOTIFY US THAT SHE HAD MASTITIS AND WAS TAKING ANTIBIOTICS BECAUSE THE PUMP WAS NOT WORKING RIGHT, AND NOT EMPTYING HER BREASTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784031 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA INC 57081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other