BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 7027530 · Received November 14, 2017

    Report

    Report Number
    1419937-2017-00316
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    October 24, 2017
    Report Date
    November 14, 2017
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE CONDUCTED TROUBLESHOOTING WITH THE CUSTOMER, INCLUDING INSPECTING THE FACEPLATE AND BACKPLATE FOR DAMAGE; INSPECTING AND CLEANING THE DIAPHRAGM; DISASSEMBLING, INSPECTING AND CLEANING THE KIT AND TUBING; AND VERIFYING CORRECT BREAST SHIELD FIT. DURING TROUBLESHOOTING, IT WAS IDENTIFIED THAT ONE OF THE STALOK CLIPS APPEARED TO MOVE A LITTLE. THE PUMP WAS REPLACED FOR THE CUSTOMER. MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER TO GET ADDITIONAL INFORMATION WENT UNANSWERED. 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 TO MEDELA LLC THAT HER PUMP IN STYLE BREAST PUMP WAS PRODUCING A KNOCKING NOISE IN THE LET DOWN PHASE . SHE REPORTED THAT SHE HAD MASTITIS, FOR WHICH SHE WAS PRESCRIBED AN ANTIBIOTIC, AND SHE ADDITIONALLY ALLEGED THAT THE PUMP WAS NOT EMPTYING HER BREASTS IN TWO PLACES, AS SHE FELT THE SUCTION WAS NOT ADEQUATE. SHE INDICATED THAT SHE HAS USED THE PUMP FOR TWO CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808022 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA LLC 57081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other