BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREASTPUMP PNSA STARTER

    MDR report key: 8102842 · Received November 26, 2018

    Report

    Report Number
    1419937-2018-00253
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    November 2, 2018
    Manufacturer
    MEDELA LLC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT REPLACEMENT BREASTSHIELDS TO HELP RESOLVE THE ISSUE. THE CUSTOMER WAS CONTACTED BY A COMPLAINT HANDLER ON MULTIPLE OCCASIONS TO GET ADDITIONAL INFORMATION, WITH NO RESPONSE AS OF THE DATE OF THIS REPORT MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATION WAS PRESCRIBED). THE INSTRUCTIONS FOR USE PROVIDES INSTRUCTIONS FOR BREAST SHIELD SIZING, INCLUDING REFERENCE TO MEDELABREASTSHIELDS.COM AND REFERRAL TO A LACTATION CONSULTANT FOR ASSISTANCE IN CHOOSING THE CORRECT SIZE BREAST SHIELD.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT SHE EXPERIENCED PAIN AND NIPPLE SCABS WHEN PUMPING WITH HER PUMP IN STYLE BREAST PUMP. SHE ADDITIONALLY ALLEGED THAT SHE HAD SEEN HER DOCTOR AND WAS PRESCRIBED ORAL ANTIBIOTICS AND A TOPICAL CREAM. THE CUSTOMER WAS LOOKING FOR BREAST SHIELDS SMALLER THAN THE 21MM SIZE THAT MEDELA OFFERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940370 BREASTPUMP PNSA STARTER PUMP, BREAST, POWERED HGX MEDELA LLC 57081 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other