BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 6045517 · Received October 20, 2016

    Report

    Report Number
    1419937-2016-00271
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 23, 2016
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2016 THE CUSTOMER RESPONDED TO AN EMAIL FROM A MEDELA CLINICIAN SAYING THAT HER ULTRASOUNDS WAS NEGATIVE AND THAT SHE DID NOT REMEMBER WHAT ANTIBIOTIC THE PHYSICIAN PRESCRIBED, BUT THAT SHE NO LONGER HAS CLOGGED DUCTS OR MASTITIS. ON (B)(4) 2016 A MEDELA CLINICIAN CONTACTED THE CUSTOMER BY PHONE. THE CUSTOMER REPORTED TO THE CLINICIAN THAT HER PUMP IS NOT BROKEN, THAT SHE HAD BEEN USING THE PUMP ON THE MAXIUM PRESSURE AND THIS WAS CAUSING THE LOUD NOISE. THE CUSTOMER ALSO REPORTED THAT SHE HASN'T HAD MASTITIS OR CLOGGED DUCTS RECENTLY. 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

    ON (B)(6) 2016 THE CUSTOMER REPORTED TO A MEDELA CUSTOMER SERVICE REPRESENTATIVE THAT HER PUMP HAD LOW SUCTION. AT THE SAME TIME SHE ALSO REPORTED THAT SHE HAD CLOGGED DUCTS AND SHE HAD BEEN PRESCRIBED MEDICATION FOR THEM AND WAS SCHEDULED TO HAVE AN ULTRASOUND AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695201 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA, INC. 57081

    Patients

    Seq Age Sex Outcome Treatment
    1 Other